The enactment of laws and ordinances and their regulation by official organs of a nation, state, or other legislative organization. It refers also to health-related laws and regulations in general or for which there is no specific heading.
Laws and regulations, pertaining to the field of medicine, proposed for enactment or enacted by a legislative body.
Laws concerned with manufacturing, dispensing, and marketing of drugs.
An area of recreation or hygiene for use by the public.
Laws and regulations concerned with industrial processing and marketing of foods.
Exercise of governmental authority to control conduct.
Contamination of the air by tobacco smoke.
Personal devices for protection of heads from impact, penetration from falling and flying objects, and from limited electric shock and burn.
A course or method of action selected, usually by a government, from among alternatives to guide and determine present and future decisions.
Prohibition against tobacco smoking in specific areas to control TOBACCO SMOKE POLLUTION.
A process whereby representatives of a particular interest group attempt to influence governmental decision makers to accept the policy desires of the lobbying organization.
Laws and regulations pertaining to the field of dentistry, proposed for enactment or recently enacted by a legislative body.
The level of governmental organization and function below that of the national or country-wide government.
The collective designation of three organizations with common membership: the European Economic Community (Common Market), the European Coal and Steel Community, and the European Atomic Energy Community (Euratom). It was known as the European Community until 1994. It is primarily an economic union with the principal objectives of free movement of goods, capital, and labor. Professional services, social, medical and paramedical, are subsumed under labor. The constituent countries are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, and the United Kingdom. (The World Almanac and Book of Facts 1997, p842)
Laws and regulations, pertaining to the field of pharmacy, proposed for enactment or enacted by a legislative body.
Decisions, usually developed by government policymakers, for determining present and future objectives pertaining to the health care system.
The aggregate business enterprise of agriculture, manufacture, and distribution related to tobacco and tobacco-derived products.
Containers, packaging, and packaging materials for drugs and BIOLOGICAL PRODUCTS. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available.
Laws and regulations, pertaining to the field of veterinary medicine, proposed for enactment or enacted by a legislative body.
Legal guarantee protecting the individual from attack on personal liberties, right to fair trial, right to vote, and freedom from discrimination on the basis of race, color, religion, sex, age, disability, or national origin. (from http://www.usccr.gov/ accessed 1/31/2003)
Activities concerned with governmental policies, functions, etc.
The act or practice of killing or allowing death from natural causes, for reasons of mercy, i.e., in order to release a person from incurable disease, intolerable suffering, or undignified death. (from Beauchamp and Walters, Contemporary Issues in Bioethics, 5th ed)
Laws and regulations concerning hospitals, which are proposed for enactment or enacted by a legislative body.
Organized efforts to insure obedience to the laws of a community.
The complex of political institutions, laws, and customs through which the function of governing is carried out in a specific political unit.
Inhaling and exhaling the smoke of burning TOBACCO.
Restraining belts fastened to the frame of automobiles, aircraft, or other vehicles, and strapped around the person occupying the seat in the car or plane, intended to prevent the person from being thrown forward or out of the vehicle in case of sudden deceleration.
Branch of medicine concerned with the prevention and control of disease and disability, and the promotion of physical and mental health of the population on the international, national, state, or municipal level.
The contamination of indoor air.
Place or physical location of work or employment.
The killing of infants at birth or soon after.
Laws and regulations, pertaining to the field of nursing, proposed for enactment by a legislative body.
Legal process required for the institutionalization of a patient with severe mental problems.
Activity involved in transfer of goods from producer to consumer or in the exchange of services.
The level of governmental organization and function at the national or country-wide level.
Innovation and improvement of the health care system by reappraisal, amendment of services, and removal of faults and abuses in providing and distributing health services to patients. It includes a re-alignment of health services and health insurance to maximum demographic elements (the unemployed, indigent, uninsured, elderly, inner cities, rural areas) with reference to coverage, hospitalization, pricing and cost containment, insurers' and employers' costs, pre-existing medical conditions, prescribed drugs, equipment, and services.
Programs in which participation is required.
Fundamental claims of patients, as expressed in statutes, declarations, or generally accepted moral principles. (Bioethics Thesaurus) The term is used for discussions of patient rights as a group of many rights, as in a hospital's posting of a list of patient rights.
Control which is exerted by the more stable organizations of society, such as established institutions and the law. They are ordinarily embodied in definite codes, usually written.
The interchange of goods or commodities, especially on a large scale, between different countries or between populations within the same country. It includes trade (the buying, selling, or exchanging of commodities, whether wholesale or retail) and business (the purchase and sale of goods to make a profit). (From Random House Unabridged Dictionary, 2d ed, p411, p2005 & p283)
The rights of the individual to cultural, social, economic, and educational opportunities as provided by society, e.g., right to work, right to education, and right to social security.
The right of the patient or the patient's representative to make decisions with regard to the patient's dying.
The use of a bicycle for transportation or recreation. It does not include the use of a bicycle in studying the body's response to physical exertion (BICYCLE ERGOMETRY TEST see EXERCISE TEST).
Accidents on streets, roads, and highways involving drivers, passengers, pedestrians, or vehicles. Traffic accidents refer to AUTOMOBILES (passenger cars, buses, and trucks), BICYCLING, and MOTORCYCLES but not OFF-ROAD MOTOR VEHICLES; RAILROADS nor snowmobiles.
The attitude of a significant portion of a population toward any given proposition, based upon a measurable amount of factual evidence, and involving some degree of reflection, analysis, and reasoning.
The privacy of information and its protection against unauthorized disclosure.
Procedures, such as TISSUE CULTURE TECHNIQUES; mathematical models; etc., when used or advocated for use in place of the use of animals in research or diagnostic laboratories.
Efforts and designs to reduce the incidence of unexpected undesirable events in various environments and situations.
The decision process by which individuals, groups or institutions establish policies pertaining to plans, programs or procedures.
The act or practice of calling public attention to a product, service, need, etc., especially by paid announcements in newspapers, magazines, on radio, or on television. (Random House Unabridged Dictionary, 2d ed)
Legal documents that are declarations of individuals' wishes regarding the disposal of their property or estate after death; esp: written instruments, legally executed, by which dispositions are made of estates. LIVING WILLS are written declarations regarding prolongation of life by extraordinary means.
Exclusive legal rights or privileges applied to inventions, plants, etc.
The state of being free from intrusion or disturbance in one's private life or affairs. (Random House Unabridged Dictionary, 2d ed, 1993)
An international organization whose members include most of the sovereign nations of the world with headquarters in New York City. The primary objectives of the organization are to maintain peace and security and to achieve international cooperation in solving international economic, social, cultural, or humanitarian problems.
Formal voluntary or governmental procedures and standards required of hospitals and health or other facilities to improve operating efficiency, and for the protection of the consumer.
Control of drug and narcotic use by international agreement, or by institutional systems for handling prescribed drugs. This includes regulations concerned with the manufacturing, dispensing, approval (DRUG APPROVAL), and marketing of drugs.
That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.
Property, such as patents, trademarks, and copyright, that results from creative effort. The Patent and Copyright Clause (Art. 1, Sec. 8, cl. 8) of the United States Constitution provides for promoting the progress of science and useful arts by securing for limited times to authors and inventors, the exclusive right to their respective writings and discoveries. (From Black's Law Dictionary, 5th ed, p1014)
The rights of women to equal status pertaining to social, economic, and educational opportunities afforded by society.
The kind of action or activity proper to the judiciary, particularly its responsibility for decision making.
Governmental levies on property, inheritance, gifts, etc.
Two-wheeled, engine-driven vehicles.
Active euthanasia of a patient at the patient's request and/or with the patient's consent.
A legal concept that an accused is not criminally responsible if, at the time of committing the act, the person was laboring under such a defect of reason from disease of the mind as not to know the nature and quality of the act done or if the act was known, to not have known that what was done was wrong. (From Black's Law Dictionary, 6th ed)
The N-glucuronide conjugate of cotinine is a major urinary metabolite of NICOTINE. It thus serves as a biomarker of exposure to tobacco SMOKING. It has CNS stimulating properties.
The science or philosophy of law. Also, the application of the principles of law and justice to health and medicine.
The promotion and maintenance of physical and mental health in the work environment.
Human artificial insemination in which the semen used is that of a man other than the woman's husband.
The application of current standards of morality to past actions, institutions, or persons.
The effect of environmental or physiological factors on the driver and driving ability. Included are driving fatigue, and the effect of drugs, disease, and physical disabilities on driving.
The moral and ethical bases of the protection of animals from cruelty and abuse. The rights are extended to domestic animals, laboratory animals, and wild animals.
The legal authority or formal permission from authorities to carry on certain activities which by law or regulation require such permission. It may be applied to licensure of institutions as well as individuals.
Insurance providing benefits to cover part or all of the psychiatric care.
A person who has not attained the age at which full civil rights are accorded.
Interference with the FREEDOM or PERSONAL AUTONOMY of another person, with justifications referring to the promotion of the person's good or the prevention of harm to the person. (from Cambridge Dictionary of Philosophy, 1995); more generally, not allowing a person to make decisions on his or her own behalf.
The protection of animals in laboratories or other specific environments by promoting their health through better nutrition, housing, and care.
Traumatic injuries involving the cranium and intracranial structures (i.e., BRAIN; CRANIAL NERVES; MENINGES; and other structures). Injuries may be classified by whether or not the skull is penetrated (i.e., penetrating vs. nonpenetrating) or whether there is an associated hemorrhage.
Failing to prevent death from natural causes, for reasons of mercy by the withdrawal or withholding of life-prolonging treatment.
The principles of professional conduct concerning the rights and duties of the physician, relations with patients and fellow practitioners, as well as actions of the physician in patient care and interpersonal relations with patient families.
Promotion and protection of the rights of children; frequently through a legal process.
Experimentation on, or using the organs or tissues from, a human or other mammalian conceptus during the prenatal stage of development that is characterized by rapid morphological changes and the differentiation of basic structures. In humans, this includes the period from the time of fertilization to the end of the eighth week after fertilization.
Time period from 1901 through 2000 of the common era.
The administrative procedures involved with acquiring TISSUES or organs for TRANSPLANTATION through various programs, systems, or organizations. These procedures include obtaining consent from TISSUE DONORS and arranging for transportation of donated tissues and organs, after TISSUE HARVESTING, to HOSPITALS for processing and transplantation.
The use of animals as investigational subjects.
A course or method of action selected to guide and determine present and future decisions.
The act or practice of killing for reasons of mercy, i.e., in order to release a person or animal from incurable disease, intolerable suffering, or undignified death. (from Beauchamp and Walters, Contemporary Issues in Bioethics, 5th ed)
Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.
Payment, or other means of making amends, for a wrong or injury.
Self-directing freedom and especially moral independence. An ethical principle holds that the autonomy of persons ought to be respected. (Bioethics Thesaurus)
Revealing of information, by oral or written communication.
The ability to understand the nature and effect of the act in which the individual is engaged. (From Black's Law Dictionary, 6th ed).
A legal requirement that designated types of information acquired by professionals or institutions in the course of their work be reported to appropriate authorities.
Conception after the death of the male or female biological parent through techniques such as the use of gametes that have been stored during his or her lifetime or that were collected immediately after his or her death.
The promotion and support of consumers' rights and interests.
Small-arms weapons, including handguns, pistols, revolvers, rifles, shotguns, etc.
The rights of individuals to act and make decisions without external constraints.
Use of written, printed, or graphic materials upon or accompanying a product or its container or wrapper. It includes purpose, effect, description, directions, hazards, warnings, and other relevant information.
The monitoring of the level of toxins, chemical pollutants, microbial contaminants, or other harmful substances in the environment (soil, air, and water), workplace, or in the bodies of people and animals present in that environment.
Provision (by a physician or other health professional, or by a family member or friend) of support and/or means that gives a patient the power to terminate his or her own life. (from APA, Thesaurus of Psychological Index Terms, 8th ed).
Production of drugs or biologicals which are unlikely to be manufactured by private industry unless special incentives are provided by others.
Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
Psychiatry in its legal aspects. This includes criminology, penology, commitment of mentally ill, the psychiatrist's role in compensation cases, the problems of releasing information to the court, and of expert testimony.
Accountability and responsibility to another, enforceable by civil or criminal sanctions.
The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.
State plans prepared by the State Health Planning and Development Agencies which are made up from plans submitted by the Health Systems Agencies and subject to review and revision by the Statewide Health Coordinating Council.
Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data.
A large group of diseases which are characterized by a low prevalence in the population. They frequently are associated with problems in diagnosis and treatment.
Women who allow themselves to be impregnated with the understanding that the offspring are to be given over to the parents who have commissioned the surrogate.
Public attitudes toward health, disease, and the medical care system.
Federal, state, or local government organized methods of financial assistance.
Drugs manufactured and sold with the intent to misrepresent its origin, authenticity, chemical composition, and or efficacy. Counterfeit drugs may contain inappropriate quantities of ingredients not listed on the label or package. In order to further deceive the consumer, the packaging, container, or labeling, may be inaccurate, incorrect, or fake.
Withholding or withdrawal of a particular treatment or treatments, often (but not necessarily) life-prolonging treatment, from a patient or from a research subject as part of a research protocol. The concept is differentiated from REFUSAL TO TREAT, where the emphasis is on the health professional's or health facility's refusal to treat a patient or group of patients when the patient or the patient's representative requests treatment. Withholding of life-prolonging treatment is usually indexed only with EUTHANASIA, PASSIVE, unless the distinction between withholding and withdrawing treatment, or the issue of withholding palliative rather than curative treatment, is discussed.
Written, witnessed declarations in which persons request that if they become disabled beyond reasonable expectation of recovery, they be allowed to die rather than be kept alive by extraordinary means. (Bioethics Thesaurus)
Informed consent given by a parent on behalf of a minor or otherwise incompetent child.
An institutional policy of granting authority to health personnel to perform procedures on patients or to remove organs from cadavers for transplantation unless an objection is registered by family members or by the patient prior to death. This also includes emergency care of minors without prior parental consent.
Transfer of preovulatory oocytes from donor to a suitable host. Oocytes are collected, fertilized in vitro, and transferred to a host that can be human or animal.
The quality or state of relating to or affecting two or more nations. (After Merriam-Webster Collegiate Dictionary, 10th ed)
Any enterprise centered on the processing, assembly, production, or marketing of a line of products, services, commodities, or merchandise, in a particular field often named after its principal product. Examples include the automobile, fishing, music, publishing, insurance, and textile industries.
Organizations comprising wage and salary workers in health-related fields for the purpose of improving their status and conditions. The concept includes labor union activities toward providing health services to members.
The largest country in North America, comprising 10 provinces and three territories. Its capital is Ottawa.
The exposure to potentially harmful chemical, physical, or biological agents that occurs as a result of one's occupation.
Contamination of the air, bodies of water, or land with substances that are harmful to human health and the environment.
An oath, attributed to Hippocrates, that serves as an ethical guide for the medical profession.
Use of written, printed, or graphic materials upon or accompanying a food or its container or wrapper. The concept includes ingredients, NUTRITIONAL VALUE, directions, warnings, and other relevant information.
Tissue, organ, or gamete donation intended for a designated recipient.
International organizations which provide health-related or other cooperative services.
Accidental or deliberate use of a medication or street drug in excess of normal dosage.
The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.
Processes or methods of reimbursement for services rendered or equipment.
A systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. The text may be cursive or in outline form but is generally a comprehensive guide to problems and approaches in any field of activity. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available.
The geographic area of Latin America in general and when the specific country or countries are not indicated. It usually includes Central America, South America, Mexico, and the islands of the Caribbean.
Guideline for determining when it is morally permissible to perform an action to pursue a good end with knowledge that the action will also bring about bad results. It generally states that, in cases where a contemplated action has such double effect, the action is permissible only if: it is not wrong in itself; the bad result is not intended; the good result is not a direct causal result of the bad result; and the good result is "proportionate to" the bad result. (from Solomon, "Double Effect," in Becker, The Encyclopedia of Ethics, 1992)
Economic aspects related to the management and operation of a hospital.
Predetermined sets of questions used to collect data - clinical data, social status, occupational group, etc. The term is often applied to a self-completed survey instrument.
Laws and regulations pertaining to devices used in medicine, proposed for enactment, or enacted by a legislative body.
Generally refers to the amount of protection available and the kind of loss which would be paid for under an insurance contract with an insurer. (Slee & Slee, Health Care Terms, 2d ed)
Damage inflicted on the body as the direct or indirect result of an external force, with or without disruption of structural continuity.
A specialized agency of the United Nations designed as a coordinating authority on international health work; its aim is to promote the attainment of the highest possible level of health by all peoples.
The protection of genetic information about an individual, family, or population group, from unauthorized disclosure.
Reproductive rights rest on the recognition of the basic right of all couples and individuals to decide freely and responsibly the number, spacing and timing of their children and to have the information and means to do so, and the right to attain the highest standard of sexual and reproductive health. They also include the right of all to make decisions concerning reproduction free of discrimination, coercion and violence.
Organized efforts by communities or organizations to improve the health and well-being of the child.
Organized services to provide mental health care.
Decisions for determining and guiding present and future objectives from among alternatives.
The provision of monetary resources including money or capital and credit; obtaining or furnishing money or capital for a purchase or enterprise and the funds so obtained. (From Random House Unabridged Dictionary, 2d ed.)
The degree to which individuals are inhibited or facilitated in their ability to gain entry to and to receive care and services from the health care system. Factors influencing this ability include geographic, architectural, transportational, and financial considerations, among others.
The area that lies between continental North and South America and comprises the Caribbean Sea, the West Indies, and the adjacent mainland regions of southern Mexico, Central America, Colombia, and Venezuela.
Time period from 2001 through 2100 of the common era.
The care provided to women and their NEWBORNS for the first few months following CHILDBIRTH.
Centers for acquiring and storing semen.
The interrelationship of medicine and religion.
Encouraging consumer behaviors most likely to optimize health potentials (physical and psychosocial) through health information, preventive programs, and access to medical care.
Termination of pregnancy under conditions allowed under local laws. (POPLINE Thesaurus, 1991)
The killing of animals for reasons of mercy, to control disease transmission or maintain the health of animal populations, or for experimental purposes (ANIMAL EXPERIMENTATION).
That distinct portion of the institutional, industrial, or economic structure of a country that is controlled or owned by non-governmental, private interests.
Elements, compounds, mixtures, or solutions that are considered severely harmful to human health and the environment. They include substances that are toxic, corrosive, flammable, or explosive.
Use of marketing principles also used to sell products to consumers to promote ideas, attitudes and behaviors. Design and use of programs seeking to increase the acceptance of a social idea or practice by target groups, not for the benefit of the marketer, but to benefit the target audience and the general society.
An enduring, learned predisposition to behave in a consistent way toward a given class of objects, or a persistent mental and/or neural state of readiness to react to a certain class of objects, not as they are but as they are conceived to be.
Drugs considered essential to meet the health needs of a population as well as to control drug costs.
Standards of conduct that distinguish right from wrong.
Promotion and protection of the rights of patients, frequently through a legal process.
Payment by a third-party payer in a sum equal to the amount expended by a health care provider or facility for health services rendered to an insured or program beneficiary. (From Facts on File Dictionary of Health Care Management, 1988)
Components of a national health care system which administer specific services, e.g., national health insurance.
Individuals supplying living tissue, organs, cells, blood or blood components for transfer or transplantation to histocompatible recipients.
Medicines that can be sold legally without a DRUG PRESCRIPTION.
The industry concerned with processing, preparing, preserving, distributing, and serving of foods and beverages.
The effort of two or more parties to secure the business of a third party by offering, usually under fair or equitable rules of business practice, the most favorable terms.
Insurance coverage providing compensation and medical benefits to individuals because of work-connected injuries or disease.
Insurance providing coverage of medical, surgical, or hospital care in general or for which there is no specific heading.
Clinical and laboratory techniques used to enhance fertility in humans and animals.
Payments or services provided under stated circumstances under the terms of an insurance policy. In prepayment programs, benefits are the services the programs will provide at defined locations and to the extent needed.
The exposure to potentially harmful chemical, physical, or biological agents in the environment or to environmental factors that may include ionizing radiation, pathogenic organisms, or toxic chemicals.
The smallest continent and an independent country, comprising six states and two territories. Its capital is Canberra.
An interactive process whereby members of a community are concerned for the equality and rights of all.
A preconceived judgment made without factual basis.
Protective measures against unauthorized access to or interference with computer operating systems, telecommunications, or data structures, especially the modification, deletion, destruction, or release of data in computers. It includes methods of forestalling interference by computer viruses or so-called computer hackers aiming to compromise stored data.
Declarations by patients, made in advance of a situation in which they may be incompetent to decide about their own care, stating their treatment preferences or authorizing a third party to make decisions for them. (Bioethics Thesaurus)
Persons with psychiatric illnesses or diseases, particularly psychotic and severe mood disorders.
Devices used to protect and restrain infant and child automotive passengers.
Groups set up to advise governmental bodies, societies, or other institutions on policy. (Bioethics Thesaurus)
Application of marketing principles and techniques to maximize the use of health care resources.
Studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at one particular time. This contrasts with LONGITUDINAL STUDIES which are followed over a period of time.
A state of prolonged irreversible cessation of all brain activity, including lower brain stem function with the complete absence of voluntary movements, responses to stimuli, brain stem reflexes, and spontaneous respirations. Reversible conditions which mimic this clinical state (e.g., sedative overdose, hypothermia, etc.) are excluded prior to making the determination of brain death. (From Adams et al., Principles of Neurology, 6th ed, pp348-9)
Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.
Health insurance plans for employees, and generally including their dependents, usually on a cost-sharing basis with the employer paying a percentage of the premium.
Health insurance coverage for all persons in a state or country, rather than for some subset of the population. It may extend to the unemployed as well as to the employed; to aliens as well as to citizens; for pre-existing conditions as well as for current illnesses; for mental as well as for physical conditions.
Administrative units of government responsible for policy making and management of governmental activities.
Abortion induced to save the life or health of a pregnant woman. (From Dorland, 28th ed)
Relations of an individual, association, organization, hospital, or corporation with the publics which it must take into consideration in carrying out its functions. Publics may include consumers, patients, pressure groups, departments, etc.

The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: information for the investigator. (1/355)

The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose" (Federal Food, Drug, and Cosmetic Act). Conducting a clinical investigation may require an approved IDE application. The US Food and Drug Administration encourages early interaction with the agency through the pre-IDE process during the development of a device or technology and during the preparation of an IDE application. This facilitates approval of the IDE application and progression into the clinical investigation. This paper reviews the terminology and applicability of the IDE regulation and the type of study that requires an IDE application to the Food and Drug Administration. The pre-IDE process and the development of an IDE application for a significant risk study of a cardiovascular device are discussed.  (+info)

Whose policy is it anyway? International and national influences on health policy development in Uganda. (2/355)

As national resources for health decline, so dependence on international resources to finance the capital and recurrent costs is increasing. This dependence, combined with an increasing emphasis on policy-based, as opposed to project-based, lending and grant-making has been accompanied by greater involvement of international actors in the formation of national health policy. This paper explores the process of health policy development in Uganda and examines how major donors are influencing and conflicting with national policy-making bodies. Focusing on two examples of user fees and drugs policies, it argues that while the content of international prescriptions to strengthen the health system may not be bad in itself, the process by which they are applied potentially threatens national sovereignty and weakens mechanisms for ensuring accountability. It concludes by proposing that in order to increase the sustainability of policy reforms, much greater emphasis should be placed on strengthening national capacity for policy analysis and research, building up policy networks and enhancing the quality of information available to the public concerning key policy changes.  (+info)

Financing pharmaceuticals in transition economies. (3/355)

This paper (a) provides a methodological taxonomy of pricing, financing, reimbursement, and cost containment methodologies for pharmaceuticals; (b) analyzes complex agency relationships and the health versus industrial policy tradeoff; (c) pinpoints financing measures to balance safety and effectiveness of medicines and their affordability by publicly funded systems in transition; and (d) highlights viable options for policy-makers for the financing of pharmaceuticals in transition. Three categories of measures and their implications for pharmaceutical policy cost containing are analyzed: supply-side measures, targeting manufacturers, proxy demand-side measures, targeting physicians and pharmacists, and demand-side measures, targeting patients. In pursuing supply side measures, we explore free pricing for pharmaceuticals, direct price controls, cost-plus and cost pricing, average pricing and international price comparisons, profit control, reference pricing, the introduction of a fourth hurdle, positive and negative lists, and other price control measures. The analysis of proxy-demand measures includes budgets for physicians, generic policies, practice guidelines, monitoring the authorizing behavior of physicians, and disease management schemes. Demand-side measures explore the effectiveness of patient co-payments, the impact of allowing products over-the-counter and health promotion programs. Global policies should operate simultaneously on the supply, the proxy demand, and the demand-side. Policy-making needs to have a continuous long-term planning. The importation of policies into transition economy may require extensive and expensive adaptation, and/or lead to sub-optimal policy outcomes.  (+info)

New federal office will spend millions to regulate herbal remedies, vitamins. (4/355)

The new Office of Natural Health Products promises better regulation of herbal remedies, but its creation raises many questions.  (+info)

German drug agency approves mifepristone.(5/355)

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Thimerosal in vaccines: a joint statement of the American Academy of Pediatrics and the Public Health Service. (6/355)

The Food and Drug Administration (FDA) Modernization Act of 1997 called for FDA to review and assess the risk of all mercury-containing food and drugs. In line with this review, U.S. vaccine manufacturers responded to a December 1998 and April 1999 FDA request to provide more detailed information about the thimerosal content of their preparations that include this compound as a preservative. Thimerosal has been used as an additive to biologics and vaccines since the 1930s because it is very effective in killing bacteria used in several vaccines and in preventing bacterial contamination, particularly in opened multidose containers. Some but not all of the vaccines recommended routinely for children in the United States contain thimerosal.  (+info)

Self-medication of antibacterials without prescription (also called 'over-the-counter' use). A report of a Working Party of the British Society for Antimicrobial Chemotherapy. (7/355)

The availability of antimicrobial agents for self-medication may increase and could include antibacterial agents for oral or topical use. Wholesale deregulation of antibacterials would be undesirable and likely to encourage misuse of classes of agents currently important in the management of serious infections. Changed regulation from Prescription-Only Medicine (POM) to Pharmacy (P) medicine of selected agents with indications for short-term use in specific minor infections and illness is likely to have advantages to the user. However, safeguards to their use would need to be included in the Patient Information Leaflet (PIL). Agents and indications for self-medication are discussed. Any alteration in licensed status from POM to P will require careful risk-benefit assessment, including the likely impact on bacterial resistance. Safety issues also include concerns relating to age of the user, pregnancy, underlying disease and the potential for drug interactions. The importance of appropriate information with the PIL is emphasized, as is the role of the pharmacist, while ways of improving adverse event notification and monitoring are discussed. The paucity of good denominator-controlled data on the prevalence of in-vitro resistance is highlighted, and recommendations for improving the situation are made. There are currently no levels of resistance accepted by regulatory bodies on which to base a licensing decision, be it for granting a product licence, renewal of a licence or a change in licensed status from POM to P. Due consideration should be given to: the validation of user-defined indications in comparison with those medically defined; the enhancement of pharmacy advice in the purchase of such agents; improved safety monitoring; the establishment of systematic surveillance of susceptibility data.  (+info)

Recommendations regarding the use of vaccines that contain thimerosal as a preservative. (8/355)

On October 20, 1999, the Advisory Committee on Immunization Practices (ACIP) reviewed information about thimerosal in vaccines and received updates from CDC's National Immunization Program and several vaccine manufacturers on the current and anticipated availability of vaccines that do not contain thimerosal as a preservative. The review was prompted by a joint statement about thimerosal issued July 8, 1999, by the American Academy of Pediatrics (AAP) and the Public Health Service (PHS) (1) and a comparable statement released by the American Academy of Family Physicians (2). These statements followed a Congressionally mandated Food and Drug Administration (FDA) review of mercury in drugs and food, which included a reassessment of the use of thimerosal in vaccines.  (+info)

It is possible to apply for an authorisation for a single product (the same product), which is identical to another authorised biocidal product (the reference product), or for which an application for such authorisation has been submitted (the prospective reference product).. This can happen regardless of whether the related reference product is a single product or an individual product of a biocidal product family.. Furthermore, it is possible to apply for national authorisation starting from a (prospective) reference product having (or seeking to have) a Union authorisation.. Products subject to the simplified authorisation procedure are also covered by this regulation.. An application for an authorisation for a same biocidal product family (Union, national or simplified) starting from a (prospective) reference product family is also possible.. The same biocidal product application process will result in an independent authorisation, but with the same expiry date as for the reference ...
Biotherapeutic products (biotherapeutics) have a successful record in treating many life-threatening and chronic diseases. However, their cost has often been high, thereby limiting their access to patients, particularly in developing countries. Recently, the expiration of patents and/or data protection for the first major group of originators biotherapeutics has ushered in an era of products that are designed to be similar to a licensed originator product. These products rely, in part, for their licensing on prior information regarding safety and efficacy obtained with the originator products. The clinical experience and established safety profile of the originator products should contribute to the development of similar biotherapeutic products (SBPs). A variety of terms, such as biosimilar products, follow-on protein products and subsequent-entry biologics have been coined by different jurisdictions to describe these products.. The term generic medicine is used to describe chemical, ...
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According to the invention, the identification information transmission path is separated from the system side, in order to wirelessly transmit information from a mobile authorisation device (30) of the user to the security module (20). To this end, the security module (20) comprises two interfaces (210, 212), namely one (210) for communication with the terminal (10) and another (212) for wireless communication with the mobile authorisation device (30). Said mobile authorisation device (30) supplies the security module (20) with identification information which is to be subjected to an authentication check therein, said information being either stored in a memory (312) in the authorisation device (30) or produced in other ways, for example, by biometric sensors, by a keyboard or the like. The security module (20) which checks the identification information, for example, preferably by means of a zero-knowledge method or a zero-knowledge protocol, only displays a request for action from a terminal
International research-focussed healthcare group Chiesi, has announced that the European Commission has granted the marketing authorisation for Lamzede® (velmanase alfa).. This is the first enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis (AM) - an ultra-rare, progressive, and debilitating disease. Patients present with a broad range of symptoms and their long-term prognosis is generally poor, with reduced life expectancy.1. The authorisation means velmanase alfa is now approved for use in the 31 European countries covered by the European Medicines Agency (EMA).. The Marketing Authorisation has been granted under exceptional circumstances according to the EU legislation, which aims to enable treatment of extremely rare disorders for which traditional large-scale clinical studies are not feasible.. Exposure to velmanase alfa has been investigated in 34 patients ranging in age from 6 to 35 years, in five ...
Per Article 66 of the REACH Regulation, downstream user notifications are to be submitted to ECHA within 3 months of first delivery of substances or formulations following authorisation. If you have received product after the authorisation date and are unsure if it falls under a granted authorisation, please contact your supplier. As a specific condition of the GCCA Authorisations, you must include in your notification the key functionalities that apply to your use. The following substance-specific key functionality worksheets provide a mechanism to address this requirement: ...
ECHA met with representatives of Industry to provide an update on its preparatory activities for the implementation of the authorisation process and to gather stakeholders input in an efficient and transparent manner. ECHA met with representatives of Industry to provide an update on its preparatory activities for the implementation of the authorisation process and to gather stakeholders input in an efficient...
BEERSE, Belgium, Oct. 15, 2013- Janssen Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat.
Medicine development is an increasingly global activity, with the aspiration to develop a common data set to address the scientific needs of regulatory agencies around the world. A consolidated data package in a standardised format does conserve resources-on both sides of the table-and its availability does support the approach of simultaneous submissions of the dossier to two or more regulatory agencies-which in turn would lend itself to work sharing among regulatory agencies and stimulate the uptake of reliance models.22-24 The findings described in this paper contribute to the study of regulatory harmonisation by providing an analysis of the extent to which the regulatory outcomes between EMA and FDA were aligned, identical, or different for new medicines submitted for evaluation simultaneously to the two agencies. Our study demonstrates that there generally is alignment between NAS approval status for EMA and FDA and that drug applications were mostly approved by both agencies. Our analysis ...
ECHA regularly assesses the substances from the Candidate List to determine which ones should be included in the Authorisation List as a priority. The prioritisation is mainly based on information in the registration dossiers on uses and volumes of the substances on the EU market that fall within the scope of the authorisation requirement. Any information submitted during the previous step (i.e. the identification of SVHCs) will also be taken into consideration.. The consultation on the draft recommendation for inclusion of substances in the Authorisation List mainly concerns the proposed Authorisation List entries for the prioritised substances, which include details on timelines and exemptions. In this context, information on the complexity of the supply chain is particularly welcome. ECHA also welcomes comments on the review periods, the transitional arrangements and on those uses which could possibly be exempted from the authorisation requirement. When proposing such exemptions, the ...
Druids are perhaps the most versatile class when it comes to raiding, capable of doing just about anything and they are sometimes called on to do a little bit of everything. After all, with the exception of the Paladin, they are the only class in the game than can fulfill all three roles of healing, tanking and DPS at the same time.. Therefore, it is imperative that you get yourself a good Druid PvE guide to assist you in mastering all these aspects of your character. This is especially the case if you have just reached level 85 on your Druid and want to start running instances with your character.. You will need to have a good idea of what to expect, as well what others expect of you in a PvE environment.. To start with, a good Druid PvE guide should tell you how to heal properly, as a Restoration spec Druid can stand toe to toe with the best healers in the game. Excellent raid healers, their vast array of different spells and HoTs make them highly effective healers especially during those ...
Janssen-Cilag International NV (Janssen) today announced the submission of an Extension Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for paliperidone palmitate once-every-three-months formulation for the treatment of schizophrenia. If approved, it will be the first antipsychotic schizophrenia medication to be administered four times a year.
Conclusions on four active substances and two applications for Union authorisation ECHA/NR/19/47 The Biocidal Products Committee (BPC) adopted seven opinions supporting the approval of...
This study presents applications of size-exclusion chromatography (SEC) for characterization and quality control of novel biotherapeutic products, including antibody-drug conjugates, hydrophobic proteins, and coformulations. Examples of modifying SEC mobile-phase composition and running conditions to modulate the separation are discussed, as well as approaches and strategies for analyzing atypical protein products such as coformulations.
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the European Commission has granted marketing authorisation for Trelegy Ellipta
BALLERUP, Denmark, July 20, 2017 /PRNewswire/ -- LEO Pharma today announced that the European Commission has granted marketing authorisation for Kyntheum(R)
Learning of the initial provisional authorisation granted in 2004, the claimants legal predecessor informed the German Patent and Trade Mark Office of this development. Time passed. In January 2006, a year and a half after the claimants legal predecessor had applied for a plant protection product certificate, the German Patent and Trade Mark Office decided to turn down the application. The reason given for the refusal was that the authorisation which enabled Poncho Pro to be put on the German market had been rather a special one. It had been an emergency authorisation granted in accordance with Article 8(4) of Directive 91/414. The Directives provision allows for a limited use of a plant protection substance where this appears necessary because of an unforeseeable danger that cannot be contained by other means. As such, the authorisation had run for only 120 days covering the period from 15 January 2004 until 13 May 2004. Since the claimants application had been made on the 14 May 2004, the ...
Orion Corporation has received favorable pharmacokinetic study results with combined salmeterol-fluticasone formulation of the Easyhaler product family and based on the results Orion is planning to apply for a marketing authorisation for the product in Europe.
Armoured Combat:Combat_Authorisation_Requirements#General,2.1.3.a.i]] has been updated to clarify that a Heavy Combatant authorisation allows the participant to engage in heavy combat with melee weapons and to take the field as Plumed Combatant or Plumed Auxiliary. And [[Armoured Combat:Combat_Authorisation_Requirements#General,2.1.3.a.ii]] has been updated that to act as a Plumed Combatant, a fighter also needs another weapon authorisation such as thrown weapon, combat archery or siege engine. Plumed Participant on its own only allows a fighter to act as a Plumed Auxiliary (banner bearer ...
Armoured Combat:Combat_Authorisation_Requirements#General,2.1.3.a.i]] has been updated to clarify that a Heavy Combatant authorisation allows the participant to engage in heavy combat with melee weapons and to take the field as Plumed Combatant or Plumed Auxiliary. And [[Armoured Combat:Combat_Authorisation_Requirements#General,2.1.3.a.ii]] has been updated that to act as a Plumed Combatant, a fighter also needs another weapon authorisation such as thrown weapon, combat archery or siege engine. Plumed Participant on its own only allows a fighter to act as a Plumed Auxiliary (banner bearer ...
Passengers from countries that are subject to the Visa Waiver Programme are required to apply for a supplementary authorisation to enter the United St
Passengers from countries that are subject to the Visa Waiver Programme are required to apply for a supplementary authorisation to enter the United St
In addition to the above, no permission is required by the MNB for non-metallic reproductions of forint coins and other forint con reproductions made for illustration purposes of paper or other non-metallic substances, and the reproductions of forint coins made available through electronic means, on an Internet website, by a wire-based or wireless device.. As of 1 November 2014, reproduction of the commemorative coins issued by the MNB may only be manufactured from metal base material based on the MNBs authorisation, irrespective of the graphic representation and the technical parameters thereof. ...
He have been having an issue trying to get GameCircle integrated into our app Rollercoaster Tycoon Classic. Everything works normally for APKs which are built and installed locally, but once they are uploaded to the Live App Testing phase the sign-in process fails and the user is logged in as Guest.. We have tried re-generating the API key several times, and double checked the certificate checksums, and it always signs in properly until the Live App Testing phase. I have seen others mention that google code can cause issues, but we have removed all code related to google libraries (GCM, analytics etc) and still get the issue.. Here is the log output which shows the authorisation which returns NOT_AUTHORIZED:. I/com.amazon.identity.auth.device.appid.AbstractAppIdentifier: isAPIKeyValid : packageName=com.atari.mobile.rctcamz. I/com.amazon.identity.auth.device.appid.AbstractAppIdentifier: getAppInfo : ...
Study finds tobacco companies in 1980s and 1990s put pressure on drug companies to limit their marketing of nicotine gum and skin patches that help people quit smoking; research led by Dr Lisa Bero is published in Journal of the American Medical Assn (M)
The Act. The Federal Meat Inspection Act, as amended, (34 Stat. 1260, as amended, 81 Stat. 584, 84 Stat. 438, 92 Stat. 1069, 21 U.S.C., sec. 601 et seq. ).. Adulterated Generally, impure, unsafe, or unwholesome; however, the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act contain separate language defining in very specific (and lengthy) terms how the term adulterated will be applied to the foods each of these laws regulates. Products found to be adulterated under these laws cannot enter into commerce for human food use.. Agricultural Marketing Act of 1946 The Agricultural Marketing Act of 1946 (AMA) (as amended) provides USDA with the authority to inspect, certify, and identify the class, quality, quantity, and condition of agricultural products (including food animal products) in interstate commerce on a voluntary, fee-for-service basis that covers program costs.. Amenable Includes cattle, swine, ...
Authorisation applications have to be accompanied by a programme of operations. Member States have to grant or refuse authorisation within six months of submission of a complete application.. Introduction of a procedure for reciprocity with third countries. Member States must inform the Commission of any authorisation of a direct or indirect subsidiary of one or more parent undertakings in third countries and of any holding acquired by a parent undertaking in a Community investment firm such that the latter would become its subsidiary.. Whenever it appears to the Commission that a third country is not granting Community investment firms effective market access comparable to that granted by the Community to investment firms from that country, it may initiate negotiations in order to secure comparable competitive opportunities for Community investment firms.. The competent authorities of the home Member State are responsible for the prudential supervision of an investment firm. However, ...
Bold simplicity is sometimes the very essence of what makes a great tone….uh…..great!. We think the Druid is possibly the greatest sounding single-knob fuzz being made today.. Just because its small doesnt mean that it isnt a force of beastly fuzz. Its big, its brash, and it wants to be heard. If youre into choppin heads, this is your pedal.. The Druid sounds equally great on bass or guitar. The thick low end ensures that our four string friends wont lose any beef in their sound.. Like all of our pedals, the Druid is true bypass, powers up with a typical Boss/Ibanez type 2.1mm center pin negative power adapter (no batteries), comes with a 1 year warranty and is built by hand in our garage.. Specifications:. Length= 4.39 ...
Some crazy ideas being suggested for the next patch expansion. Troll Druids? Thats just crazy. Stupid too. Lore is in the bathroom getting sick. I guess the Trolls hang up their skull crafting and start worshiping the Earth Mother? Why not just go all out crazy? Gnome Druids. If we have Gnome Druids then I…
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Creates an authorisation sub-resource of the consent resource and start the authorisation process.. The usage of this access method is only necessary if the TPP has asked to start the authorisation process separately from the consent establishment (using the TPP-Explicit-Authorisation-Preferred Header). ...
It is intended in combination with docetaxel for the treatment of locally-advanced, metastatic or locally-recurrent NSCLC of adenocarcinoma histology
Indicated for prevention of acute and delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy
The production of biotherapeutics including antibodies and antibody fragments is a rapidly expanding market with an increasing number of products being approved for use. One of the major platforms used for production of such therapeutics is Escherichia coli, which offers a rapid production at low production costs. The favoured location for targeting these biotherapeutic is the periplasm of E. coli as this environment supports the formation of disulphide bonds and simplifies the purification process. There are a number of periplasmic release procedures currently practised in industry including osmotic shock. However their limitations call for the development of an improved generic periplasmic release method ...
Hyaluronic acid is commercially available on the European market for the indication of joint arthrosis, as either a medicinal product or as a medical device. The classification into one of the two product classes depends on the effect of the product on the human body. Marketing as a medicinal product implies pharmacological, metabolic or immunological activity. The mechanism of action stated by the manufacturer or the marketing authorisation holder has a decisive influence on this classification. If the molecular weight is under 1 million Da the pharmacological effect is thought to be dominant. Hyaluronic acid of higher molecular weight is said to act mainly by physical effects.. There is essentially no difference between the two classes of product with respect to safety in clinical studies. There are only minimal differences in the regulations on non-clinical studies or on the planning and performance of clinical studies.. Comparison of the studies performed with the medicinal product ...
Plexpress, developer of the innovative TRAC (Transcript Analysis with the aid of Affinity Capture) platform for high-throughput gene expression analysis, has announced dedicated ADME-Tox programs for contract research organizations (CROs). This follows FDA draft guidance suggesting measurement of CYP mRNA levels for ADME-Tox studies, and EMA final guidelines stating that mRNA analysis should be used in drug interaction studies in order to increase the sensitivity of assays.
So I kinda skimmed cause there were a lot of posts, but I have always thought it would be cool if the tanks spec for druids was moonkin, and we pull threat from all spells. I have never put much thought into how that would work for druids, but more for the game itself. If you increased the differentiation between what kind of tanks you need for certain encounters you could really open up the game more. For instance bosses that are more susceptible to casters would need a caster tank to hold agro. Or perhaps if bliz designed bosses that attacked using range and needed a lot of LOS within the strat, you would then need a ranged tank, ie. boomkin tank, could also be uses often for kiting adds throughout encounters, could be cool ...
Hey everyone, Im building a core for BRF, and was wondering if i can have two druid restoration, someone could tell ?In addition, the hots are staking or...
Resto Druid Guide Updated for 5.4 ________________________________________________ Hey all, I will be updating the guide VERY SOON, bear with me. My time has been very filled lately with rl events, but the time has come to refocus on the class/spec we all know and love. Thanks for the patience! A huge thank you to Dendrek for keeping up amazing druid guides for so long and always adding a lot to this guide. Thanks also to Fumsy for originally updating this for MoP. Also a big thanks to
and similar expressions, and are based on our current beliefs and expectations. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that unexpected concerns may arise from additional data or analysis, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates, or we may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities and risks relating to our collaborations with third parties, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a ...
The launch was sequel to the authorisation of the Prudential Regulation Authority(PRA) and the Financial Conduct Authority(FCA) for UBA UK Limited to carry out full scale wholesale banking across the United Kingdom.. With this launch, UBA Group further consolidates its unique positioning as the first and only Sub-Saharan African financial institution with banking operations in both the United Kingdom and the United States, thus reinforcing its strong franchise as Africas Global Bank, facilitating trade and capital flows between Africa and the world, the bank explained.. Speaking at the event, the Group Chairman, UBA, Mr. Tony Elumelu, said the Group was excited by the authorisation of the relevant regulatory authorities in the United Kingdom for UBA to upgrade its operation and further fulfil its aspiration of deepening trade and investments flows between Africa and Europe.. The enhancement of our business in the United Kingdom is very timely and mutually beneficial for African and European ...
Microinsurance Regulatory Framework Geraldine Desiderio Country Bankers Life 2010 RBAP‐MABS Na.onal Roundtable Conference …
Cyltezo®, adalimumab biosimilar from Boehringer Ingelheim, approved in Europe for the treatment of multiple chronic inflammatory diseases
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June we received an FDA EUA for the test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching software, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.. We are ...
Health,in cancer research between Europe and the USA. Dr Jnsson said: Not on...The authors make a series of recommendations for ensuring that patient... Reducing the review time for the marketing authorisation of n... Ensuring that once authorisation is obtained the drug is ava... Ensuring that any economic evaluation or health technology as...,Comparison,of,patients,access,to,new,and,better,cancer,drugs,reveals,inequalities,between,countries,medicine,medical news today,latest medical news,medical newsletters,current medical news,latest medicine news
Drug information for Lansoprazole Heartburn Relief 24 Hour by QUALITY CHOICE (Chain Drug Marketing Association). Includes: facts, uses, warnings, directions and more.
Refractory Ceramic Fibres, Borates and Coal tar pitch, high temperature are listed in the 5th and 6th ECHA recommendations for substances to be included in the REACH Authorisation list (Annex XIV). The REACH Committee meeting on 21-22 October 2015 launched the discussions on their possible inclusion in the Annex XIV.. As these substances are of utmost importance to ceramic industries and their downstream users, Cerame-Unie maintains that there are socio-economic implications related to a possible inclusion. As a member of the Cross-Industry Initiative (CII), CU supports the proposal to consider workplace legislation as an alternative to REACH Authorisation. Kai Sebastien Melzer, Regulatory Affairs Manager at the Nickel Institute, spoke on this subject at the CU General Assembly on 1 December 2015.. The process is still ongoing but the REACH Committee should come to a decision in the first half of 2016.. ...
Qatar launches Electronic Travel Authorisation System. Holders of Valid Residence Permits or Visas to either GCC countries, Schengen countries, Australia, Canada, UK, USA, or New Zealand will be eligible for Electronic Travel Authorisation. System set to Further Facilitate Entry to Qatar for Visitors of All Nationalities
The Drug Enforcement Administration (DEA) today commended House and Senate negotiators for agreeing on legislation to control 26 synthetic drugs under the Controlled Substances Act. These drugs include those commonly found in products marketed as K2 and Spice.. The addition of these chemicals to Schedule I of the Controlled Substances Act will be included as part of S. 3187, the Food and Drug Administration Safety and Innovation Act. Schedule I substances are those with a high potential for abuse; have no medical use in treatment in the United States; and lack an accepted safety for use of the drug.. In addition to scheduling the 26 drugs, the new law would double the length of time a substance may be temporarily placed in schedule I (from 18 to 36 months). In addition to explicitly naming 26 substances, the legislation creates a new definition for cannabamimetic agents, creating criteria by which similar chemical compounds are controlled. ...
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the European Commission has granted marketing authorisation for Nucala® (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in adult patients. As a result Nucala is now approved for use in the 31 European countries covered by the European Medicines Agency (EMA).
Abstract: European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic products have existed since the 1990s and remain the publicly available standard
The European Commission has granted Komboglyze (saxagliptin and metformin HCl immediate-release fixed dose combination) a marketing authorisation for adults with type II diabetes.. The indication is an adjunct to diet and exercise to improve glycaemic control after the medication demonstrated favourable results in clinical trials.. Komboglyze combines the recently approved Onglyza (saxagliptin), a DPP-4 inhibitor, and metformin immediate-release (metformin IR), a biguanide, in a convenient tablet.. The approval covers the 27 Member States of the European Union.. By the end of this year, its expected that nearly 53 million people aged between 20 and79 in Europe will suffer from diabetes. This figure is expected to rise to more than 64 million by 2030.. The treatment is another compound developed by Bristol-Myers Squibb and AstraZenecas collaboration, started in 2007, aimed at researching and commercialising select investigational products for type II diabetes. ...
Tokyo, Japan 26th November, 2018 - Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that it has received a European Commission decision granting a marketing authorisation to POTELIGEO® (Generic name: mogamulizumab), a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
VALIDATION BY EMA OF THE filing MARKETING AUTHORISATION FOR EPTACOG BETA, THE LFB RECOMBINANT FACTOR VIIA , AND PUBLICATION OF THE EXPLORATORY IN VITRO STUDY RESULTS on eptacog beta in combination with emicizumab
The Australian Competition and Consumer Commission has announced it has decided to grant interim authorisation to a joint venture company between GrainCorp and the Australian Wheat Board (AWB) to provide transport and logistics services to the companies in Queensland, New South Wales and Victoria for export bound grain.
The Board of the Financial Supervisory Authority (ASF) has decided, during the meeting on 19.02.2020, to withdraw the operating authorisation of the company CERTASIG Societate de Asigurare si Reasigurare S.A (CERTASIG), due to the fact that the company did not restored the level of eligible own funds covering the minimum capital requirement (MCR) within the term provided by law, wrote Romanian insurance portal 1asig.ro.
With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance 5- methoxy-N,N-dimethyltryptamine (5-MeO-DMT), including its salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act (CSA). This action by the DEA Deputy Administrator is based on a scheduling recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and a DEA review indicating that 5-MeO-DMT meets the criteria for placement in schedule I of the CSA. This final rule will impose the criminal sanctions and regulatory controls of schedule I substances under the CSA on the manufacture, distribution, dispensing, importation, exportation, and possession of 5-MeO-DMT ...
The Canadian Natural Health Products Directorate (NHPD) granted Frutarom a product license for its Benolea cardiovascular health support ingredient. Benolea supports cardiovascular health by maintaining healthy blood pressure levels, according to the
Data Products License Agreement - Acxiom Corp. and Publication Management Inc. and Other Business Contracts, Forms and Agreeements. Competitive Intelligence for Investors.
EFSA is responsible for the peer review of active substances used in plant protection products in the EU. Each active substance (the active component against pests/plant diseases contained in the plant protection product) has to be proven safe in terms of human health, animal health and impact on the environment. EFSA is also in charge of the risk assessment of the maximum residue levels (MRLs) of pesticides permitted in products of plant or animal origin marketed in the EU.. There are different workflows for the evaluation of new active substances, the re-evaluation of active substances for renewal of authorisation, for the setting or changing of MRLs and for basic substances.. ...
Fortunately, potential landmark designation protects 1232 Druid Hill Avenue from demolition for the next six months. But because this is only a potential landmark nomination, these protections run out in July unless the Baltimore City Council takes action first. If a member of the City Council introduces an ordinance to list the property as a full city landmark before July, the protections are immediately extended for another eighteen months. If the City Council votes to approve the ordinance and the Mayor signs it into law before the end of that period, the city gives 1232 Druid Hill Avenue landmark status forever.. Last week, we reached out to Councilman Eric Costello (who represents the Upton neighborhood as part of the 11th District) to ask him to join us in protecting this landmark and introduce a landmark designation ordinance. If you are resident of the 11th District, we urge you to reach out to Councilman Costello and share your own support for preserving 1232 Druid Hill Avenue by ...
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So… let me just say - the Druidic Order as presented in this book is really, really cool. I love the backstory, I love the intrigue, and I think its a phenomenal inspiration for druid-related stories.. But its also way too much to fit into a normal campaign. In my late review of the rogue handbook I gushed over the books thieves guild rules in a similar fashion. The difference is that those rules were simple to use and, more importantly, optional. These Druidic Order rules are a required class feature for the druid class.. Sure, theres a lot of neat stuff in here. Details on how challenges between druids play out, or the ways in which the Shadow Circle pits the various normal Circles against one another. Theres a lot of cool info about druidic festivities at the various moots, and discussions of how more powerful druids interact with new initiates.. And I would use absolutely none of it. This is all for one characters class, I might add. Either we force the entire rest of the party to ...
Ive always been a fan of high pivot bikes. Ever since those early years ridding Bromont with the Balfa crew, ive loved the concept and how the bikes worked for my style of ridding.. The high pivot is making a bit of comeback. Anyone following the past few World Cup seasons has surely seen Amaury Pierron laying waste to the gnarliest tracks aboard his Commencal. Norco has also adopted the concept on their HSP DH bike.. Ive been closely following the development of the Forbidden Bikes Druid. The Druid is an HSP, mid travel trail bike. I recently decided to pull the trigger on a frame, which I build up with some spare parts as well as some new trick bits such as the SRAM AXS group. It was baptism by fire for my shinny new Druid. She never even got a shakedown ride and was immediately thrown into the steeps and chunk in Quebec. So far the bikes has performed flawlessly and I am just dialling in the fit and contact points at this point. Suspension is mint. It certainly can gobble up the chunk but ...
Local info of Druid Hills in Jefferson county. Druid Hills has 386 residents in 2010-2014, ranked #378 in Kentucky state cities. Also Druid Hills income, school, races, crime, weather, environment and other info / rankings.
Introduction On October 27, 1970, the Congress passed the Comprehensive Drug Abuse Prevention and Control Act (P.L. 91-513, 21 U.S.C. § 801 et seq.). According to the Drug Enforcement Administration (DEA), Title II of this Act, the Controlled Substances Act, is a consolidation of numerous laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances and is the legal foundation of the governments fight against drugs and other substances.22 The Act also regulates all legal and illegal substances that are recognized as having potential for abuse or addiction. The DEA is charged with enforcing the Controlled Substances Act, including the regulation of controlled pharmaceuticals and regulated chemicals. Specifically, the DEAs diversion control program oversees and regulates the legal manufacture and distribution of controlled pharmaceuticals, which include narcotics ...
Aspartame was discovered in 1965 by a chemist working for the American company Searle and an initial marketing authorisation (MA) was granted in the United States by the Food and Drug Administration (US-FDA) in 1974. This MA was suspended a few months later following an appeal against the authorisation on the grounds that the toxic and carcinogenic effects on the brain of this compound and its metabolites had not been properly evaluated during the experimental studies. Following a reassessment of the studies on experimental animals and an examination of new data (including a study of carcinogenicity in the rat), the US-FDA granted this product a new MA in 1981 (US-FDA, FR 1981) for use in solid food. This authorisation was extended to soft drinks in 1983 (US-FDA, FR 1983) and for its use as a general sweetener in 1996. The safety of aspartame has been assessed and recognised by a number of other national and international organisations including the FAO/WHO Committee of Experts on Food Additives ...
The Drug Enforcement Administration (DEA) proposes to remove naloxegol ((5[alpha],6 [alpha])-17-allyl-6-((20-hydroxy-3,6,9,12,15,18- hexaoxaicos-1-yl)oxy)-4,5-epoxymorphinon-3,14-diol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Naloxegol is currently a schedule II controlled substance because it can be derived from opium alkaloids. This action would remove the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naloxegol ...
The PDF links below detail the various approvals for the collection, sale and/or manufacture of insignia have been obtained from Australian Defence Force Boards, full details relative to each Service are as shown within respective letters.. Colour Patch Army Emblem Authorisation. Colour Patch Navy Emblem Authorisation. Colour Patch Rising Sun Authorisation. ...
A medical practitioner contacted the Network with a question regarding whether hemp oil was legal in Minnesota and if he could have it available in his clinic for his patients.. The legality of Cannabidiol (CBD) oil has caused significant controversy. In December 2016 the federal Drug Enforcement Administration promulgated a final rule clarifying that CBD oil is a marijuana derivative, and as such is listed as a Schedule I substance under the Federal Controlled Substances Act (CSA). Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse.. In early 2017, the agency issued a clarification to the new rule specifically addressing the legal status of CBD oil. Essentially, the agency states that cannabinoids are not found in the parts of the cannabis plant that are excluded from the CSA definition of marijuana, and therefore they are listed on Schedule I. It should be noted that cannabis industry representatives have ...
The report, titled Ortho Biological Products is an in-depth analysis of the Ortho Biological Products market across the world. A brief historic overview of the Ortho Biological Products market has been mentioned in the report, followed by the present scenario of the market. The report analyses the size of the market and forecasts the valuation and the growth rate of the market in the span of next couple of years. Key drivers and restraints of the overall market has been pointed out. The report cites the various opportunities to favor the growth of the Ortho Biological Products market during the forecast period. It also indicates the key market trends shaping up the market.. The Ortho Biological Products market has certain distinct aspects. The report throws light on each of these aspects and studies the various segments of the market in detail. The growth of each of the market segments during the forecast horizon has been analyzed in the report. The present state of the Chinese economy has ...
Medicinal Products Database contains information on all medicinal products with marketing authorisation granted by HALMED as well as on medicinal products authorised by European Commission, based on the scientific assessment by European Medicines Agency (EMA).. more ...
The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder.. It is also understood by legislation that a common name is, according to Article 1(21) of Directive 2001/83/EC, as amended, The international non-proprietary name (INN) recommended by the World Health Organisation, or, if one does not exist, the usual common name.. According to Article 1(22) of Directive 2001/82/EC, the name of a veterinary medicinal product is: „The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder and according to Article 1(23) of Directive 2001/82/EC, as amended, common name is the international non-proprietary name (INN) recommended by the World Health Organisation, or, if one does not exist, the usual common ...
After the FDA approved the first U.S. biosimilar, Sandozs Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products. That has not been the case. No other U.S. biosimilar product has been approved. In addition, Pfizer recently announced that Hospiras application (now owned by Pfizer) for a biosimilar version of Amgens Epogen (EPO) had been rejected, and that it intends to resubmit its application to FDA in the first half of 2016.. EPO is a more complex biologic product than Sandozs Zarxio. It is made in genetically engineered mammalian cells as opposed to bacteria. It is larger than Zarxio and it has sugar molecules (glycosylation) attached to it. Glycosylation is variable and depends on how the product is made and the cells that are used to make it. Because biosimilars are made in living cells, rather than chemically synthesized in a laboratory the way small molecule drugs are, they can at best be similar to the approved biologic ...
After the FDA approved the first U.S. biosimilar, Sandozs Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products. That has not been the case. No other U.S. biosimilar product has been approved. In addition, Pfizer recently announced that Hospiras application (now owned by Pfizer) for a biosimilar version of Amgens Epogen (EPO) had been rejected, and that it intends to resubmit its application to FDA in the first half of 2016.. EPO is a more complex biologic product than Sandozs Zarxio. It is made in genetically engineered mammalian cells as opposed to bacteria. It is larger than Zarxio and it has sugar molecules (glycosylation) attached to it. Glycosylation is variable and depends on how the product is made and the cells that are used to make it. Because biosimilars are made in living cells, rather than chemically synthesized in a laboratory the way small molecule drugs are, they can at best be similar to the approved biologic ...
This Notice of Proposed Rulemaking (NPRM) proposes to classify the following three steroids as ``anabolic steroids under the Controlled Substances Act (CSA): boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione. The Drug Enforcement Administration (DEA) believes that this...
Though they can reduce the costs of health care, biosimilars still face challenges to access. In their article featured in Deep Dive: Market Access II, Monique Martin, Tony Lanzone and Michael Iacoviello consider the barriers and benefits.. Biosimilars, the legal almost-identical copies of biological drugs, have long been heralded as exciting new products which will allow healthcare systems to realise substantial savings. However, they have yet to make good on this promise.. To date, more than 40 biosimilars have launched in Europe, including: epoetin (EPO), insulin, human growth hormone (hGF), granulocyte-colony stimulating factor (G-CSF) and the two anti-tumour necrosis factors (anti-TNFs), etanercept and infliximab. However, these only cover a limited number of indications compared to those currently covered by biologics.. The US lags behind Europe, with only four biosimilar products launched to date. This is due, in part, to the fact that the special 351(k) regulatory pathway (Biologics ...
Following its approval by the FDA, the Drug Enforcement Administration (DEA) moved to re-schedule the drug from a Schedule 1 controlled substance under the CSA, to a Schedule 5 controlled substance. At the time, the FDA argued that this decision didnt go far enough, writing in a letter to the DEA that CBD and its salts… do not have a significant potential for abuse and could be removed from the [Controlled Substances Act (CSA)], adding, we find that CBD does not meet the criteria for placement in any of Schedules II, III, IV, or V under the CSA ...
Description The Subpoena Summons Processing Case Worker processes requests received from various legal requestors (Attorneys, state and Federal law enforcement agents, state and federal government agents) to ensure compliance and meet legal due dates. This role requires reading and understanding of various legal requests (i.e. subpoenas, summons, and authorizations); application of various complex methods, procedures and knowledge of business units production and applications; working with business line partners to gather the required records and information while adhering to policies, procedures, laws and regulatory guidelines. •Strictly following established procedures, policies and regulatory guidelines • Achieve and maintain personal and team targets, goals and objectives • Demonstrate strong research and problem solving skills • Demonstrating professional communication skills (both written and verbal) • Meet all legal due dates to be in compliance while ensuring our customer ...
The U.S. Food and Drug Administration published its long-awaited draft guidance on the development of biosimilar products today (see FDA press release), taking a significant...
The schedules of the (Canadian) Controlled Drugs and Substances Act (CDSA), with the chemical structure of each scheduled substance.
The COVID-19 pandemic has brought to the fore the critical importance of universal affordable access to internet connectivity. Despite efforts from the different stakeholders, universal affordable access is far from being achieved, as existing national operators focus their efforts on using technologies and building infrastructure in more profitable areas. This means sparsely populated areas, where household incomes are low and infrastructure costs are high, remain unconnected. As a result, there is an emerging consensus regarding the need to do something different from business as usual.. Based on recent changes in the telecommunications industry, this paper analyses solutions for the expansion of the telecommunication operator ecosystem. In particular it focuses on the local operator as the actor to fill the coverage and usage gaps left by national operators, in a complementary way. These local operators serve a much smaller and more distinct market, with deeper knowledge of their users, ...
On August 12, the US Drug Enforcement Administration (DEA) announced its rejection of two petitions seeking to reclassify marijuana as a less-regulated Schedule II substance under the federal Controlled Substances Act (CSA).
U-47700 has never been used medically, only in research, nor has it been tested on humans, until now. Responding to the imminent threat to public health and safety, the U.S. Drug Enforcement Administration has placed U-47700 into Schedule 1 of the Controlled Substances Act, effective November 14, 2016 ...
The firm plans to manufacture the controlled substances for distribution as bulk products to its customers.. Any other such applicant and any person who is presently registered with DEA to manufacture such substances may file comments or objections to the issuance of the proposed registration.. Any such comments or objections may be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, United States Department of Justice, Washington, DC 20537, Attention: DEA Federal Register Representative (CCR), and must be filed no later than July 30, 2001.. Start Signature ...
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Source: http://mtgc.com.br/2021/07/05/s05e25/ 2G Creature - Human Elf Druid Bear Form - During your turn, Druid of the Moon Circle is a Bear ...
INDIANAPOLIS, and INGELHEIM, Germany, July 8, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced that the companies marketing authorisation...
The APVMA is considering an application to approve the new active constituent, fluensulfone. The APVMA is considering an application for the registration of Mainman 500 WG Insecticide and to approve the new active constituent, flonicamid. The product is to be registered for control of woolly aphid and tuber mealybug in apples, cotton aphid and green mired in cotton, green
On September 15, the Conference of State Bank Supervisors (CSBS) issued its Model Regulatory Framework for State Regulation of Certain Virtual…
KBP1270-1467 - Labor laws and legislation. KBP1468-1569 - Social laws and legislation. KBP1572-1942 - Courts and procedure. ... Drugs. Cosmetics. K3651-3654 - Alcohol. Alcoholic beverages. K3661-3674 - Public safety. K3700-3705 - Control of social ... KB1270-1278 - Labor laws and legislation. KB1468-1550 - Social laws and legislation. Welfare. Charities. KB1572-1690 - Courts ... K7585-7595 - Social legislation. K7611-7688 - Civil procedure. International civil procedure. K7690 - Arbitration and award. ...
"Champions Drug Legislation". The Pharmaceutical Era. D. O. Haynes & Company. 40: 767. December 17, 1908. Retrieved December 9, ... A US patent 497045 A, H. W. Barker, "Drug-mixer", published 1893-05-09, issued 1893-05-09 "Drug-mixer". Google Patents. ... On May 9, 1893 he was awarded a patent for a drug mixer which he claimed could also be used to pop corn or roast coffee. Barker ... After completing high school, he "went to Minnesota 'to visit' and stayed 22 years". He worked in the drug business for 15 ...
"Federal Register of Legislation.. *^ "Förordning om ändring i förordningen (1999:58) om förbud mot vissa hälsofarliga varor" ( ... "The American Journal of Drug and Alcohol Abuse. 45 (2): 161-169. doi:10.1080/00952990.2018.1545024. PMC 6430661. PMID 30822141. ... "关于印发《非药用类麻醉药品和精神药品列管办法》的通知" (in Chinese). China Food and Drug Administration. 27 September 2015. Archived from the original on ... Drug Enforcement Administration (DEA), Department of Justice (December 2010). "Schedules of controlled
"Synthetic cannabis › What they are". NZ Drug Foundation. Archived from the original on 2015-09-21. Retrieved 2014-05-11. › ... "Poisons Standard". Federal Register of Legislation. Government of Australia. October 2015. " ... Drug and Alcohol Dependence. 60 (2): 133-40. doi:10.1016/S0376-8716(99)00152-0. PMID 10940540. Markuse P. "Forest Humus - ... and permanently instated the same schedule on 9 July 2012 in the Section 1152 of the Food and Drug Administration Safety and ...
Research chemical Designer drugs AL-LAD Brandt SD, Kavanagh PV, Westphal F, Elliott SP, Wallach J, Stratford A, et al. (October ... "Psychoactive Substances Act 2016". Legislation.gov.uk.. ... 1P-ETH-LAD is a psychedelic drug similar to LSD. Research has ... Like ETH-LAD, this drug has been reported to be significantly more potent than LSD itself, and is reported to largely mimic ETH ... 2017). "6 -ethyl-6-norlysergic acid diethylamide (ETH-LAD) and 1-propionyl ETH-LAD (1P-ETH-LAD)". Drug Testing and Analysis. 9 ...
244C DRUG ADDICTION TREATMENT CENTRE (HEI LING CHAU ADDICTION TREATMENT CENTRE) ORDER". Hong Kong e-Legislation. Hong Kong ... The Hei Ling Chau Addiction Treatment Centre is a government-run drug rehabilitation centre located on the island of Hei Ling ... CS1 maint: discouraged parameter (link) "Treatment and Rehabilitation". Community Drug Advisory Council. Retrieved 17 March ... accepting detained persons convicted of offences under the Dangerous Drugs Ordinance. As part of the government's monitoring ...
"Class C Drugs". Schedule 2 Controlled Drugs. UK Legislation.. *^ Cohen S (1977). "Diethylpropion (tenuate): an infrequently ... In the UK Amfepramone is a class C drug [8] and as a medicine, it is a Schedule 3 Controlled Drug which requires safe custody. ... "Martindale: The Complete Drug Reference. London, UK: Pharmaceutical Press. Retrieved 18 July 2014.. ... Amfepramone, also known as diethylpropion, is a stimulant drug of the phenethylamine, amphetamine, and cathinone classes that ...
1 million drug prevention tax levy backed by SOLACE and other anti-drug abuse organizations. In May 2011 the Ohio Senate and ... "Senate passes pain clinic legislation; Kasich could sign into law this week". Portsmouth Daily Times. May 17, 2011. Archived ... and an increased incidence of children born addicted to prescription drugs. For a number of years, the most prevalent drug was ... "Drug prevention levy fails". Portsmouth Daily Times. Archived from the original on 2014-08-12. Retrieved 2013-05-21. " ...
Marcus, Aaron J. (2003). "Are The Roads A Safer Place Because Drug Offenders Aren't On Them?: An Analysis Of Punishing Drug ... "Governor Murphy Signs Legislation Eliminating the Use of Mandatory Driver's License Suspensions as a Penalty for Certain Non- ... It is an excuse for young teenagers to say no to drugs, an excuse to say, "No thanks, I'd rather preserve my driving privilege ... And yes, we should jail - and in some cases even execute - those involved in the sale of drugs in this country. ... But let's ...
"Spectrum Data of the 3rd Governor-designated Drugs and the Analyses of Uncontrolled Drugs Purchased" (PDF). Tokyo Metropolitan ... "Poisons Standard". Federal Register of Legislation. Australian Government. October 2015. "关于印发《非药用类麻醉药品和精神药品列管办法》的通知" (in ... It has been reported to be sold as a designer drug, but little is known about its pharmacology or toxicology. Anecdotal user ... 4-Fluoromethamphetamine (4-FMA) is a stimulant drug related to
"The Misuse of Drugs Act 1971 (Ketamine etc.) (Amendment) Order 2014". www.legislation.gov.uk. Drug Enforcement Administration ( ... All drugs in the NBOMe series, including 25I-NBOMe, became illegal in Russia in October 2011. This substance is a Class A drug ... All drugs in the NBOMe family, including 25I-NBOMe, are illegal. UK Home Office (2014). "The Misuse of Drugs Act 1971 (Ketamine ... "Three More Synthetic Drugs Become Illegal for at Least Two Years". United States Drug Enforcement Administration (DEA). 15 ...
"Listing of Drugs Currently Regulated as New Drugs (The New Drugs List)". www.hc-sc.gc.ca. Health Canada. 26 May 2016. Retrieved ... Under the new legislation, kava is no longer listed among prohibited substances and it is therefore legal to possess, import ... Izzo AA, Ernst E. Interactions between herbal medicines and prescribed drugs: a systematic review" Drugs 2001;61(15):2163-75. ... and drugs metabolized by CYP450 in the liver. A few notable potential drug interactions are, but are not limited to: Alcohol: ...
"Misuse of Drugs Act 1971". www.legislation.gov.uk. Retrieved 10 January 2019. "The International Drug Control Conventions". ... "Drugs Misuse Regulation 1987". www.legislation.qld.gov.au. Office of the Queensland Parliamentary Counsel. Retrieved 10 January ...
"关于印发《非药用类麻醉药品和精神药品列管办法》的通知" (in Chinese). China Food and Drug Administration. 27 September 2015. Retrieved 1 October 2015. " ... "Poisons Standard". Federal Register of Legislation. The Australian Government. October 2015. " ... "Tests Show Synthetic Drug Contaminated Holiday Bread from CA Bakery". Food Safety News. 2015-02-02. " ... U.S. Department of Justice
"The Misuse of Drugs Act 1971 (Ketamine etc.) (Amendment) Order 2014". www.legislation.gov.uk. "2016 - Final Rule: Placement of ... The drug was also implicated in the death of an 18-year old male, however it was not reported whether the presence of the drug ... "关于印发《非药用类麻醉药品和精神药品列管办法》的通知" (in Chinese). China Food and Drug Administration. September 27, 2015. Archived from the original on ... This substance is a Class A drug in the United Kingdom as a result of the N-benzylphenethylamine catch-all
Wyden expressed optimism at the chances of passing national common sense gun legislation, noting that legislation passed in ... "Compromise Sought On Drug Coverage". New York Times. May 27, 2000.. *^ "Bush Nominees for Health and Transportation Are ... "United States Senate Legislation and Records. November 24, 2003. Retrieved September 21, 2007.. ... Wyden said gun violence "demands real action by Congress" and the legislation "takes a long-overdue critical step in the right ...
"Misuse of Drugs Act 1975 No 116, Public Act 8 Exemptions from sections 6 and 7". www.legislation.govt.nz. 22 December 2016. ... In New Zealand, pseudoephedrine is currently classified as a Class B Part II controlled drug in the Misuse of Drugs Act 1975, ... Attempts to control the sale of the drug date back to 1986, when federal officials at the Drug Enforcement Administration (DEA ... Fearing this would limit legitimate use of the drug, lobbyists from over the counter drug manufacturing associations sought to ...
Center for Drug Evaluation and Research (15 December 2017). "FDA Drug Safety Communication: New restrictions, contraindications ... "Poisons Standard June 2017". legislation.gov.au. Retrieved 7 January 2018. "Archived copy". Archived from the original on 1 ... "Effect of CYP3A5*3 Polymorphism on Pharmacokinetic Drug Interaction between Tacrolimus and Amlodipine". Drug Metabolism and ... Several drugs interact with amlodipine to increase its levels in the body. CYP3A inhibitors, by nature of inhibiting the enzyme ...
Talking Drugs. Retrieved November 15, 2017. "Marijuana Decriminalization Legislation Passed By House". 7 News Belize. 20 ... Commission on Narcotic Drugs (1949). Summary of Annual Reports of Governments Relating to Opium and Other Narcotic Drugs. Dirk ... "Mexico Legalizes Drug Possession". The New York Times. 21 August 2009. Retrieved 2010-04-04. TNI. "Argentina - Drug Law Reform ... Hemp Drugs Commission (1893-1894); Sir William Mackworth Young (1969). Marijuana: Report of the Indian Hemp Drugs Commission, ...
"Food Safety Legislation Key Facts". U.S. Food and Drug Administration. Retrieved April 26, 2011. "About FDA". U.S. Food and ... The legislation affects every aspect of the U.S. food system, from farmers to manufacturers to importers. It places significant ... It is considered the first major piece of federal legislation addressing food safety since 1938. It is also the first piece of ... The FSMA has given the Food and Drug Administration (FDA) new authorities to regulate the way foods are grown, harvested and ...
The Food and Drug Administration must rely on its Adverse Event Reporting System to monitor adverse events that occur with ... Legislation. Fda.gov (15 September 2009). Retrieved on 2010-11-12. "Adverse Event Reporting System (AERS)". FDA. 20 August 2009 ... Most countries place dietary supplements in a special category under the general umbrella of foods, not drugs. As a result, the ... U.S. Food and Drug Administration. CFR - Code of Federal Regulations Title 21. Retrieved 16 February 2014. not EUR-Lex - ...
"Legislation - Controlled Substances". U.S. Food and Drug Administration. 11 June 2009. Archived from the original on 4 February ... Pholcodine is not prescribed in the United States where it is classed as a Schedule I drug, the most highly controlled drug ... Pholcodine is a drug which is an opioid cough suppressant (antitussive). It helps suppress unproductive coughs and also has a ... With an average half-life of approximately 2.3 days, steady-state in someone taking the drug chronically would not be reached ...
"Drugs Misuse Act 1986" (PDF). legislation.qld.gov.au. Retrieved 24 November 2008.. ... "Western Australian Legislation - Industrial Hemp Act 2004". www.legislation.wa.gov.au. Retrieved 5 August 2019.. ... James F. Hopkins, "Slavery in the Hemp Industry", Drug Library *^ a b c d French, Laurence; Manzanárez, Magdaleno (2004). NAFTA ... "drug",[65] even though hemp is not a recreational drug and has the potential to be a sustainable and profitable crop for many ...
Retrieved from http://blog.nacwa.org/washing-away-triclosan-with-legislation-and-regulation/ Halden, p. 3603. Food and Drug ... In the US, triclosan is regulated as a pesticide by EPA and as a drug by FDA. EPA generally regulates uses on solid surfaces, ... Companies have one year to reformulate products without these ingredients, take them off the market or submit a New Drug ... The exceptions to this rule are individual products that have received approval from the US Food and Drug Administration for ...
The thirty-second meeting of the WHO Expert Committee on Drug Dependence (September 2000) evaluated MBDB and recommended ... Federal Register of Legislation. Australian Government. October 2015. "Svensk författningssamling" [Swedish Code of Statutes] ( ... WHO Expert Committee on Drug Dependence (2001). "Thirty-second Report, Technical Report Series 903" (PDF). "Poisons Standard". ... "Liquid chromatography-quadrupole time-of-flight mass spectrometry for screening in vitro drug metabolites in humans: ...
Brooks, Nathan (8 July 2005). "Drug Testing in Sports: Proposed Legislation" (PDF). CRS Report.[permanent dead link] "Better ... lists other performance-enhancing drugs and substances as Schedule III drugs. A series of Schedule III drugs were held, most ... enhancing drugs Biogenesis baseball scandal Pittsburgh drug trials Doping is easily spotted in blood when someone is being drug ... "NFL Players Association - Drug Policies". www.nflpa.com. Retrieved 2016-03-17. "Behind the Shield: NFL drug testing policy not ...
The Federal Insecticide Act (FIA) of 1910 was the first pesticide legislation enacted.[2] This legislation ensured quality ... Under Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), the EPA can also regulate the amount of pesticide ... any nitrogen stabilizer, except that the term "pesticide" shall not include any article that is a "new animal drug" within the ... These competing interests as well as legislation addressing access has been covered separately under Pesticide regulation in ...
COVID-19 drug development. *COVID-19 drug repurposing research. E. *Exposure to COVID-19 ...
The Medicaid Drug Rebate Program and the Health Insurance Premium Payment Program (HIPP) were created by the Omnibus Budget ... Under 2017 American Health Care Act (AHCA) legislation under the House and Senate, both versions of proposed Republican bills ... "Medicaid Drug Rebate Program Overview". HHS. Archived from the original on December 14, 2007.. ... This program was formed due to the costs that Medicaid programs were paying for outpatient drugs at their discounted prices.[14 ...
They were also more likely to have problems with alcohol and illegal drugs than those women who did not have an abortion. The ... legislation has been proposed by pro-life advocates requiring abortion providers to tell a woman that the embryo or fetus may ... A woman is given methotrexate, usually as a shot in a doctor's office, and the drug stops the embryo from staying attached to ... 90.9% were done by curettage, 7.7% were medical abortions (using drugs, mifepristone in most cases), 0.4% by "intrauterine ...
In 1998, the National Drug Policy was approved, whose purpose is to ensure safety, efficacy, and quality of drugs, as well as ... Procedures for the registration, control, and labelling of foods are established under federal legislation, which assigns ... In 2000, there were 14 industries authorized to produce generic drugs and about 200 registered generic drugs were being ... Brazil is among the greatest consumers markets for drugs, accounting for 3.5% share of the world market. To expand the access ...
Derby, C. D. (2014). "Cephalopod Ink: Production, Chemistry, Functions and Applications". Marine Drugs. 12 (5): 2700-2730. doi: ... this legislation was extended to include all cephalopods[155] in accordance with a general EU directive.[156] ...
Kucinich responded: "It was a Republican Congress and there weren't many Democrats passing meaningful legislation during a ... During his 2004 presidential campaign, Kucinich expressed support for a drug policy that "sets reasonable boundaries for ... rights in supporting progressive legislation.[123] In the past, states attempting to enact single-payer reforms have been ...
Pharmacology is the study of drugs and their actions.. *Photobiology is the study of the interactions between non-ionizing ... While the US healthcare system has come under fire for lack of openness,[18] new legislation may encourage greater openness. ... of Essential Drugs and Medicines Policy (2002). "Traditional medicine: growing needs and potential". World Health Organization. ... Medications (Rx): what drugs the patient takes including prescribed, over-the-counter, and home remedies, as well as ...
S. 1685: Fairness in Drug Sentencing Act of 2007, govtrack.us, accessed October 27, 2010. S. 1711: Drug Sentencing Reform and ... Legislation to reduce the disparity has been introduced since the mid-1990s, culminating in the signing of the Fair Sentencing ... 473 Effectiveness of the War on Drugs, Drug Policy Alliance, accessed October 17, 2010. Johnson, Carrie (October 16, 2009). " ... The Anti-Drug Abuse Act of 1986 implemented the initial disparity, reflecting Congress's view that crack cocaine was a more ...
"The impact of smokefree legislation in England: evidence review" (PDF). Department of Health. March 2011. Retrieved 14 February ... Drug Testing and Analysis. 11 (1): 140-156. doi:10.1002/dta.2471. hdl:10072/382912. PMID 30109771.. ... "Smokefree legislation consultation response, The Institute of Public Health in Ireland". Archived from the original on 8 ... Russia was one of the last countries in the world not to have anti-smoking legislation in place. However, in October 2012, ...
American chiropractors found that a slight majority favored allowing them to write prescriptions for over-the-counter drugs.[37 ... a conversion program for people with other health care education and limited training programs for regions where no legislation ...
U.S. Food and Drug Administration. Retrieved 2010-10-15.. *^ "Title 21-Food and drugs: Chapter i-Food and drug administration: ... In September 2012, the European Commission proposed new legislation aimed at enhancing safety, traceability, and transparency.[ ... U.S. Food and Drug Administration. Retrieved 2010-10-15.. *^ a b c d e f "General and Special Controls". Medical Devices. U.S. ... United States (Food and Drug Administration)Edit. Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act[6] defines a ...
It was replicated in other parts of the city and country and led to national legislation.[19] The Nehemiah homes were funded by ... Many social problems associated with poverty from crime to drug addiction have been prevalent in the area for decades. Despite ...
LegislationEdit. In Carmel-by-the-sea, California, heels over 2 inches high, with less than one square inch of bearing surface ... "Men Just Weren't Made to do This: Performances of Drag at 'Walk a Mile in Her Shoes' Marches." Gender and Society, vol. 24, no ... In April 2017, the Canadian province of British Columbia amended workplace legislation to prevent employers from requiring ... Existing legislation allows women to be required to wear high heels, but only if it is considered a job requirement and men in ...
People would tie a rope around the necks and drag them over to a ditch."[249] Corpses were stacked along the streets of ... Bekker, Konrad (Summer 1951). "Land Reform Legislation in India". Middle East Journal. 5 (3): 319-36. JSTOR 4322295.. ... The bodies were picked over by vultures and dragged away by jackals. Sometimes this happened while the victim was still living. ... Advanced anti-malarial drugs such as mepacrine (Atabrine) were distributed almost solely to the military and to "priority ...
Food and Drug Administration - Agency of the US Department of Health and Human Services (US FDA) ... If stipulated in any EU product legislation, assessment by a Notified Body or manufacture according to a certified production ... Manufacturers have to check, on their sole responsibility, which EU legislation they need to apply for their products. ... with no independent check of the conformity of the product with EU legislation; ANEC has cautioned that, amongst other things, ...
At the Federal level, consistent with Section 341 of the Federal Food, Drug, and Cosmetic Act,[67] the Food and Drug ... "Rules for the Review of Legislation on Production of Flour and Pasta (English Translation)" (PDF). Union of Organisations of ... "Food, Drug, and Cosmetic Act, Title 21, Chapter 9, S. IV, Sec. 341" (PDF). Retrieved 7 July 2012.. ... "Rules for the Review of Legislation on Production of Flour and Pasta". Italian Government Printing Office. Retrieved 7 July ...
"legislation.gov.uk.. *^ "Misuse of Drugs Act 1971 (Amendment) (No. 2) Order 2014 - Motion to Approve: 12 May 2014: House of ... Khat is a controlled drug for the purpose of the Misuse of Drugs Act 1977 and Schedule 1 of the Misuse of Drugs Regulations ... Khat drug profile The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) ... "ADF - Alcohol & Drug Foundation. Retrieved 2017-10-03.. *^ "Import restrictions: Kava and Khat , Office of Drug Control". www. ...
There have been efforts to combat anti-asexual discrimination through legislation or education (such as through workshops on ... Labour Party parliamentary candidate George Norman called for Parliament to add asexuality to its existing equality legislation ...
"Nitschke held over drug kits in NZ". Australian Broadcasting Corporation. July 2009. Retrieved 22 July 2009.. ... This put him in a position of an informal spokesperson for the proposed legislation.[5] After the Rights of the Terminally Ill ... "WA Police search homes of Exit International group members for euthanasia drug Nembutal". Australian Broadcasting Corporation. ... 15 February 2010). "Young people gain access to euthanasia drug". Sydney Morning Herald. Retrieved 26 July 2014. ...
2003 War on Drugs. In his 4 December 2002 speech on the eve of his birthday, King Bhumibol spoke about the rise in drug use, ... Bhumibol only vetoed legislation on rare occasions. In 1976, when the Parliament voted 149-19 to extend democratic elections ... On 14 January 2003, Thaksin launched a campaign to rid "every square inch of the country" of drugs.[61] His "war on drugs" ... Thailand: Public Senses War On Drugs Futile 20 March 2005 *^ "พระราชดำรัส พระราชทานแก
Similar legislation attempted in California and other states[edit]. The Humane Society and other animal protection advocates ... Opponents of Prop 2 note that a process called "traceback" is conducted by the Food and Drug Administration (FDA) and helps to ... Food & Drug Administration. 2003. "Guide to Investigation of Eggs and Farms Implicated In Foodborne Outbreaks of Salmonella ... "Farm Sanctuary Applauds Colorado for Passing Legislation Phasing out Veal and Gestation Crates". Reuters. 2008-05-14. Archived ...
... (from U.S. Food and Drug Administration). *Some Relevant UK Statutory Instruments *The Medicines for ... European Union: In the EU, Good Clinical Practice (Directive 2001/20/EC) is backed and regulated by formal legislation ... United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA),[1] they are not statutory ... Kimmelman, Jonathan; Weijer, Charles; Meslin, Eric M (2009). "Helsinki discords: FDA, ethics, and international drug trials". ...
List of legislation regulating underwater diving. *Investigation of diving accidents. *UNESCO Convention on the Protection of ... Effects of drugs on fitness to dive. *Fitness to dive. *Psychological fitness to dive ...
The drug does not appear on the FDA list of drugs or categories of drugs that present "demonstrable difficulties" for ... "Compounding Legislation Action Center - Section 503A". National Home Infusion Association. 2010. Archived from the original on ... Drug testing and reporting of incidents[edit]. Poor practices on the part of drug compounders can result in contamination of ... In the Drug Quality and Security Act (DQSA) of 2013 (H.R. 3204),[15] Congress amended the Federal Food, Drug, and Cosmetic Act ...
v. Parrish, upholding minimum-wage laws and other New Deal legislation, marked "the triumph of our own socialist revolution" ... She was the lone justice to contend that a provision in the California Constitution requires drug offenders be given treatment ... The job included diverse duties, ranging from analysis of administration policy, court decisions, and pending legislation to ...
... presumed to contain drugs, and took it to a known drug apartment soon afterward. The warrant states that this event was ... "In Wake Of Protests, Democrats To Unveil Police Reform Legislation". NPR. Archived from the original on June 25, 2020 ... In a variety of statements, Glover said that Taylor had no involvement in the drug operations, that as a favor she held money ... The warrant also stated that a car registered to Taylor had been seen parked on several occasions in front of a "drug house" ...
"legislation.gov.uk. The National Archives. Retrieved 30 May 2016.. *^ "Global Anglicanism at a Crossroads". PewResearch.org. 19 ...
Iron is commonly found in the Earth's crust in the form of an ore, usually an iron oxide, such as magnetite or hematite. Iron is extracted from iron ore by removing the oxygen through its combination with a preferred chemical partner such as carbon which is then lost to the atmosphere as carbon dioxide. This process, known as smelting, was first applied to metals with lower melting points, such as tin, which melts at about 250 °C (482 °F), and copper, which melts at about 1,100 °C (2,010 °F), and the combination, bronze, which has a melting point lower than 1,083 °C (1,981 °F). In comparison, cast iron melts at about 1,375 °C (2,507 °F).[4] Small quantities of iron were smelted in ancient times, in the solid state, by heating the ore in a charcoal fire and then welding the clumps together with a hammer and in the process squeezing out the impurities. With care, the carbon content could be controlled by moving it around in the fire. Unlike copper and tin, liquid or solid iron dissolves ...
Items which are paid by patients who can afford it are: drugs prescribed on an outpatient basis, hearing, dental, and ... The legislation did not state that Cuba cannot purchase medicines from U.S. companies or their foreign subsidiaries; however, ... "Patients pay for drugs, hearing, dental, and orthopedic prostheses, wheelchairs, crutches, and similar items but prices are low ... In that film, Moore took a number of Americans to a hospital in Havana where they bought affordable drugs, and were given ...
Senator Bernie Sanders is backing two pieces of legislation that would introduce price controls and allow drug imports from ... Does importing drugs save money?. The other legislation Sanders is promoting is a bill that would allow Americans to buy ... Wakana said his organization supports the drug importation legislation as well as the CREATES Act introduced in Congress last ... Consumer groups welcome the pieces of legislation.. "Patients are struggling so much right now with skyrocketing drug prices," ...
Medicare Prescription Drug Legislation. NEW: The Medicare Drug War. Public Citizen report on how drug companies and HMOs led an ... Safe & Affordable Drugs & Devices [4] Prescription drugs are unaffordable and new drugs and devices often are approved without ... Comments on the FDAs Draft Guidance on Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under ... Prescription Drug Reimportation Bill. Testimony of Peter Lurie, MD, MPH, Deputy Director of Public Citizens Health Research ...
... consider further incorporating mental health treatment into her efforts to address New Hampshires heroin and prescription drug ... Ayotte, a Republican, is co-sponsoring several pieces of legislation related to drug addiction treatment, including one that ... about a third of which involved heroin alone or in combination with other drugs. In 2013, there were 193 drug-related deaths. ... hospital officials told her that the number of infants born at the hospital after being exposed to drugs in the womb has more ...
... but accomplish nothing with respect to reducing demand for drugs or preventing deadly drug overdoses. Maryland's governor ... should move away from the criminal justice system as the mechanism for addressing drug use and overdose, and should instead ... Drug-induced homicide laws may fulfill an instinct for retribution, ... Prosecutors hope harsh drug charges will deter those who sell drugs and keep drugs away from users. However, no evidence exists ...
The Food and Drug Administration currently is unable to approve generic copies of expensive biotech drugs.. "I urge the ... Democrat Calls on President to Push Generic Biotech Drug Legislation. by Sam Savage ... on Monday called on President Barack Obama to speed up legislation that would approve the use of generic biotech drugs.. Rep. ... he urged the President to take steps that would prepare for and even begin to approve biotech drugs in advance of legislation. ...
... and ISMP announced their strong support for the Mitigating Emergency Drug Shortages (MEDS) Act, introduced today by Senators ... drug shortages MEDS Act U.S. Food And Drug Administration Advocacy Patient Safety Legislation ... Healthcare Groups Applaud New Legislation to Address Drug Shortages. MEDS Act Introduced by Collins, Smith Increases FDA ... We believe this legislation is a significant step in addressing our nations drug shortage crisis, and supports our goal of ...
Tennessees legislature is preparing to give its approval to a bill that would criminalize some drug-addicted pregnant women, ... Tennessee Passes Legislation to Criminally Prosecute Drug-Addicted Pregnant Women Tennessees legislature is preparing to give ... "This piece of legislation is an intervention," she said, adding "Do you want help for yourself, and do you want help for the ... Those attempts had a couple victories in the state courts: a South Carolina Supreme Court decision agreed that drug use during ...
Designer Drugs Lead to Designer Legislation. *NAAG » NAAGazette Archive » Volume 8, Number 2 » Designer Drugs Lead to Designer ... 1]Zunny Losoya, Synthetic Drugs � Emergence, Legislation and the Criminal and Legal Aftermath of Broad Legislation, quoting ... The legislation lengthened the period of time that a drug could be temporarily scheduled, and also permanently scheduled 11 ... While all of the above legislation has helped to combat the synthetic drug epidemic, prosecutors still face many difficulties ...
Edward Kennedy and Debbie Stabenow would allow Medicare beneficiaries to obtain drug coverage directly from Medicare itself and ... Legislation Would Modify Medicare Drug Benefit. Sens. Edward Kennedy (D-Mass.) and Debbie Stabenow (D-Mich.) on Tuesday ... of the drug benefit (Carey, CQ HealthBeat. , 3/1). He said Democrats have been "scaring" beneficiaries away from the drug ... The legislation also would eliminate the so-called "doughnut hole" coverage gap -- or the gap in coverage under which Medicare ...
... require drugmakers and drug importers to pay back to the state part of the subsidies on their products and introduce looser ... Parliament passed on Monday amendments to drug legislation which will allow sales of some over-the-counter drugs outside of ... Parliament passed on Monday amendments to drug legislation which will allow sales of some over-the-counter drugs outside of ... Wholesale drug sellers will have to pay 1% of the wholesale price margin on their yearly subsidized drug sales. Producers will ...
... legislators in 31 states have proposed 82 bills that would require drug tests of TANF applicants and/or recipients.31 There was ... TANF Drug Testing Legislation) During 2010 and the first half of 2011, ... TANF Drug Testing Legislation. Share This. (TANF Drug Testing Legislation) "During 2010 and the first half of 2011, legislators ... TANF Drug Testing Legislation) "During 2010 and the first half of 2011, legislators in 31 states have proposed 82 bills that ...
Jerry Brown vetoed legislation last year to let pharmaceutical companies make not-yet-fully-approved treatments available to ... Analysis: This is a second act for the so-called "right-to-try" legislation, which Brown vetoed last year. In his veto message ... Brown said "patients with life-threatening conditions should be able to try experimental drugs" but that proposed changes to ...
House passes drug-tracing legislation. BY Alaric DeArment June 4, 2013. Get all the latest industry news in your inbox. Email ... Generic Drug Weekly Report Weekly top stories in the generic drug category ... Generic Drug Weekly Report Weekly top stories in the generic drug category. ... DSN A.M. Daily news stories covering the retail drug industry Breaking News First-to-the-market with developing stories in the ...
The legislation would remove the concerns of doctors and patients in states allowing the use of medical marijuana that they ... will be prosecuted from running afoul of federal drug laws. ... The drugs they want you to be on, the side effects are worse ... Booker legislation would exempt N.J. doctors dispensing marijuana from federal drug laws. Updated: Mar. 29, 2019, 8:31 a.m. , ... The legislation would also reclassify marijuana, which is now considered under federal law to be a dangerous drug with no ...
Kanavos, Panos; Vandoros, Sotiri; Habicht, Jarno; De Joncheere, Kees; World Health Organization. Regional Office for Europe (‎Copenhagen : WHO Regional Office for Europe, 2009)‎ ...
The new legislation will make certain types of hearing aids available over-the-counter to Americans with mild to moderate ... Generic Drug Weekly Report Weekly top stories in the generic drug category ... Generic Drug Weekly Report Weekly top stories in the generic drug category. ... DSN A.M. Daily news stories covering the retail drug industry Breaking News First-to-the-market with developing stories in the ...
Congress gave final approval March 27 to long-needed legislation that will improve the safety of over-the-counter (OTC) ... Congress Passes Legislation to Reform Over-the-Counter Drug Regulation Science-based and streamlined oversight will help ... AntibioticsBiomedical ResearchFood & Drug SafetyHealth Care * Trends. Global TrendsHispanicsInternet & TechMedia & NewsReligion ... Implementation of the legislation should make it much easier for the FDA to revise monographs to reflect the latest science and ...
Drug Act to be extended for future versions of the same drug without the drugs manufacturer having to show that the drug ... introduced legislation to eliminate the "orphan drug loophole." Current law allows the Food and Drug Administration (FDA) to ... The proposed legislation would require FDA to revoke a companys orphan drug exclusivity under the "no cost recovery" criterion ... In some cases, however, even if the drug developer meets the criterion of having no hope of recovering the costs, the drug does ...
6, 2019 (ACP) - As Congress grapples with legislation to reduce the cost of prescription drugs, the American College of ... Physicians is continuing to make its views known to ensure that any legislation that moves forward is ... ACP continues to monitor legislation and provide comments to Congress to ensure transparency from manufacturers, reduction in ... Legislation to Prevent Rising Drug Costs Making Way Through House, Senate. Legislation to Prevent Rising Drug Costs Making Way ...
... list of unsafe or ineffective drugs, and reporting of bad reactions to compounded drugs or any drug that poses a safety risk. ... Drugs.com Mobile Apps. The easiest way to lookup drug information, identify pills, check interactions and set up your own ... Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and ... Allow the FDA to waive the requirement to compound drugs only if they are not copies of commercially-available drugs if doing ...
... in limiting the rising cost of prescription drugs. ... White House urgently ramps up push for drug cost legislation. ... Bennet is backing the Senate compromise and also pursuing his own legislation allowing Medicare to negotiate drug prices. ... Home » White House urgently ramps up push for drug cost legislation ... "I think its critically important for the country for us to get a bill done-a drug-pricing bill is long overdue," said Bennet. ...
Drugs Approvals and Trials. 12/12/2017 Drugs Approvals and Trials FDA approves first drug for Eosinophilic Granulomatosis with ... Home Public Health and Safety Legislation significantly decreased potentially inappropriate drug prescriptions ... "Every year, thousands of Canadians die of drug overdoses from misused prescription drugs such as opioids, benzodiazepines and ... Drugs Approvals and Trials*Environmental Health*Health Informatics*Legal and Regulatory*Life style and Fitness*Medical ...
... say a consequence of the coronavirus relief bill speeding through Congress may be to delay action on drug pricing legislation ... Drug Pricing Legislation In Doubt After COVID-19 Relief Bill. By Andrew Kragie Law360 is providing free access to its ... Were confident that going forward, prescription drug pricing and surprise billing legislation will be priorities for President ... lowering Rx drug prices Cooperation btwn us is what itll take to get drug prices lowered, the 86-year-old senator tweeted with ...
The Food, Drug, and Cosmetic Act, in MAJOR ACTS OF CONGRESS (2004). ... In addition to his interests in constitutional law and legislation, Ruger also teaches and writes in the area of health law and ...
Counting drug coupons as part of a drugs added sales price could tie the hands of independent clinicians trying to ensure ... Michael Weinstein: How drug pricing legislation can hurt patients, independent physicians. Eric Oliver - Thursday, August 29th ... Counting drug coupons as part of a drugs added sales price could tie the hands of independent clinicians trying to ensure ... includes a provision that would require drugmakers to include the value of drug coupons when calculating a drugs average sales ...
Gil Gutknecht (R-Minn.), author of a bill that would allow U.S. residents to purchase lower-cost prescription drugs from other ... More than 200 House Members Call for Vote on Prescription Drug Reimportation Legislation. Rep. Gil Gutknecht (R-Minn.), author ... calling on the drug industry to address complaints about rising prescription drug prices.. Emanuel said, "While we need to deal ... The drug industry and the Bush administration "strongly oppose" the bill, according to The Hill. . ...
Misuse of Drugs Amendment Regulations 2013. *A correction has been made in regulation 15 under section 25(1)(j)(iv) of the ... Misuse of Drugs Amendment Regulations 2013. Jerry Mateparae, Governor-General. Order in Council. At Wellington this 4th day of ... Pursuant to section 37(1)(g) of the Misuse of Drugs Act 1975, His Excellency the Governor-General, acting on the advice and ... "12C Authority for designated pharmacist prescribers to prescribe certain controlled drugs. *. "(1) A designated pharmacist ...
NAFDAC DG: Putting Drugs on Concurrent List will Cause Chaotic Drug Legislation ... prescription and enforcement of grades and minimum standards of quality for drugs and drug products; prevention of drug misuse ... These include but not limited to the following: Firm control on drugs and drug-related matters by the federal government; ... chaotic drug legislation that will discourage foreign investment and disruption of existing collaboration with international ...
Uzbekistan Food, Drugs, Healthcare, Life Sciences Kosta Legal 11 Jan 2017 ... More Popular Related Articles on Food, Drugs, Healthcare, Life Sciences from Middle East & Africa ... Adoption of new OTC drug list that includes 192 items of monotherapies and 1033 items of comprehensive medications; ...
Keywords: drugs, drug risks, limits of testing,notable risk signals, preemption, drug reform, drug legislation, drug reform ... Addressing Potential Drug Risks: The Limits of Testing, Risk Signals, Preemption and the Drug Reform Legislation. South ... legislation, Vioxx, cardiovascular risks, pre-market testing, FDA regulatory authority, Food and Drug, active drug surveillance ... Gilhooley, Margaret, Addressing Potential Drug Risks: The Limits of Testing, Risk Signals, Preemption and the Drug Reform ...
  • The waiver allowed Scully to represent the Bush Administration in negotiations with Congress over the recently-enacted Medicare prescription drug legislation while Scully simultaneously negotiated possible employment with three lobby firms and two investment firms that had a major stake in the legislation. (citizen.org)
  • We look forward to working with Congress to advance the MEDS Act, which will help prevent, mitigate and resolve drug shortages and secure the supply of these life-saving products for patients and the hospitals and health systems that proudly care for them. (newswise.com)
  • As leaders in patient safety, it is critical that the MEDS Act advance in Congress to decrease the risks of drug shortages and the impact on patient care. (newswise.com)
  • We applaud Senators Collins and Smith for their leadership on this legislation and encourage Congress to continue exploring ways to address this patient safety risk. (newswise.com)
  • Congress gave final approval March 27 to long-needed legislation that will improve the safety of over-the-counter (OTC) medications. (pewtrusts.org)
  • Sept. 6, 2019 (ACP) - As Congress grapples with legislation to reduce the cost of prescription drugs, the American College of Physicians is continuing to make its views known to ensure that any legislation that moves forward is in the best interest of internal medicine physicians and their patients. (acponline.org)
  • It's too early to tell if Congress can reach an agreement on a major bill, but ACP remains committed to the enactment of legislation," said Brian Buckley, ACP's senior associate for legislative affairs. (acponline.org)
  • We believe Congress should lower the cost of prescription drugs by enacting policies that will promote competition in the pharmaceutical industry and increase transparency in the pricing and costs associated with the development of drugs and by implementing reforms to Medicare to lower out-of-pocket costs for seniors and increase the effectiveness of drugs in the marketplace. (acponline.org)
  • I look forward to working with my colleagues in Congress on a bipartisan basis to move this legislation forward. (drugs.com)
  • We call on Congress to work in a bipartisan manner to pass Congressman Markey's legislation, which is necessary to protect our families from these predictable, preventable tragedies. (drugs.com)
  • The White House is ramping up its push to get a bill through Congress that curbs prescription drug costs, feeling a new urgency as the impeachment investigation advances amid the 2020 election campaign. (ibj.com)
  • Law360 (March 26, 2020, 8:19 PM EDT) -- Health policy experts say a consequence of the coronavirus relief bill speeding through Congress may be to delay action on drug pricing legislation even though it's a priority for leaders in both parties during this election year. (law360.com)
  • Meredith Freed, a health policy analyst at the Kaiser Family Foundation, agreed that the loss of a looming deadline 'could make it less likely that Congress will take action on prescription drug costs before the election. (law360.com)
  • If we see more legislative vehicles for economic stimulus, those could provide Congress with other avenues to push the prescription drug agenda forward,' Freed said. (law360.com)
  • We share Congress' goal of ensuring the sustainability of the Medicare program, and recognize the leadership of the Senate Finance Committee in working to lower drug prices. (beckersasc.com)
  • The Western Hemisphere Drug Policy Commission would be required to submit recommendations on future U.S. drug policy to Congress, the Secretary of State and the Office of National Drug Control Policy 12 months after its first meeting. (house.gov)
  • Their objections come on the heels of historic legislation by the U.S. Congress, which bans sweetening cigarettes with flavors or herbs such as clove. (drugs-forum.com)
  • Four former FDA commissioners have warned Congress that imported drugs can carry risks of being substandard, adulterated or fake. (fdanews.com)
  • Indeed, earlier this year the Branded Pharmaceutical Association (" BPA ") announced that the organization submitted draft legislation to Congress to create a special approval pathway for what the organization terms "legacy drugs. (fdalawblog.net)
  • In July 2007, 11 members of the House of Representatives sent a letter to FDA Commissioner Andrew von Eschenbach asking for FDA's "assurance that 'Legacy Drugs' will not be unfairly targeted before Congress has the opportunity to afford due process. (fdalawblog.net)
  • Study on Medicare Part A Drug Costs - HHS is to provide an analysis to Congress by January 1, 2021, on the spending and volume of drugs that are furnished in an inpatient setting by hospital type and size as well as the impact of drugs shortages on inpatient hospital services. (morganlewis.com)
  • Lawmakers introduced similar legislation last year that didn't advance in the Republican-controlled Congress. (bbj.hu)
  • Celebrities Lisa Marie Presley, Kelly Preston, Kirstie Alley, Jenna Elfman and Juliette Lewis joined the Citizens Commission on Human Rights (CCHR), a mental health watchdog, in applauding Congress for passing precedent-setting legislation that bans school personnel forcing parents to drug their children for classroom or behavioral problems. (laleva.org)
  • James (Jim) David Matheson Trump's budget targets affordable, reliable power Work begins on T infrastructure plan New president, new Congress, new opportunity MORE (D-Utah) - the bill's authors - strengthened provisions in the draft that would require drug manufacturers, wholesale distributers and pharmacies to be able to provide a prescription drug's entire transaction history by Jan. 1, 2015. (thehill.com)
  • Legislation to give pharmacies and drug wholesalers the ability to take advantage of lower drug prices in places like Canada , where government controls produce much lower prices, has been introduced in the new Congress. (blogspot.com)
  • In the last Republican Congress , the votes were likely there to pass a drug reimportation bill but Republican leaders in both houses blocked it. (blogspot.com)
  • Now, with both houses led by Democrats , it is very possible we will see a drug reimportation bill make it through this Congress. (blogspot.com)
  • In 2003, a Republican-majority Congress created Medicare Part D , which prevented Medicare, the country's largest single-payer health care system, from negotiating drug prices. (wikipedia.org)
  • Legislation not enacted by the end of a Congress is cleared from the books. (govtrack.us)
  • Congress enacted GDUFA to ensure patients have access to safe, high-quality, and affordable generic drugs . (fda.gov)
  • Agreed upon recommendations were sent to Congress, and Congress held hearings on GDUFA that included testimony from FDA, the generic drug industry, and other interested parties. (fda.gov)
  • Members of the public health community are aware of many of the ways the Trump administration and the 115th Congress are hindering and reversing evidence-based actions for public health - from an executive order requiring agencies to scrap two regulations each time they create a new one to advancing legislation that would make it harder for EPA to obtain and use the most up-to-date science in its work. (scienceblogs.com)
  • Company leaders believe input will help to promote the development of constructive data privacy legislation in Congress. (yahoo.com)
  • Legislation to address this problem has been introduced in Congress. (rarediseases.org)
  • This report provides an overview of the President's plan and the legislation introduced to date in the 106th Congress. (unt.edu)
  • Congress came down hard on oncologists in the Medicare Modernization Act of 2004, limiting Medicare reimbursement to the average sale price (ASP) of cancer drugs administered in doctors offices, plus 6 percent. (managedcaremag.com)
  • The legislation would permit the FDA to decide whether generic makers can skip or abbreviate human clinical trials, and supporters say that the agency would make sure the copies are safe. (bbj.hu)
  • The bipartisan legislation was supported by Sens. (drugstorenews.com)
  • Today, bipartisan legislation to combat drug shortages sponsored by U.S. Reps. Diana DeGette (CO-1) and Tom Rooney (FL-16) passed the House Energy and Commerce Committee, as part of the Prescription Drug User Fee Act (PDUFA). (votesmart.org)
  • Our bipartisan legislation will create an early warning system so the FDA, drug companies, and doctors can better respond to any shortage, quickly and efficiently, and make sure patients' health is protected. (votesmart.org)
  • The House gave initial approval Wednesday to bipartisan legislation from State Rep. Nick Schroer, R-O'Fallon. (missourinet.com)
  • Clearing the way for consideration by the US House of Representatives, the Ways and Means Committee has unanimously approved bipartisan legislation aimed at increasing drug price transparency by manufacturers and pharmacy benefit managers through enhanced reporting and accountability requirements. (morganlewis.com)
  • The $900 billion U.S. coronavirus relief and government appropriations legislation (the Act) contains several important new drug price reporting and transparency measures, including certain provisions that were part of the Senate's Prescription Drug Pricing Reduction Act of 2019 (S. 2543). (massbio.org)
  • In a rare show of bipartisanship, the House Ways and Means Committee recently approved HR 2113 , the Prescription Drug Sunshine, Transparency, Accountability and Reporting Act of 2019 (STAR Act) by a 40-0 vote. (morganlewis.com)
  • ROCKVILLE, Md. (Feb. 28, 2020) -The American Kidney Fund (AKF) applauds Senators Bill Cassidy (R-LA) and Dick Durbin (D-IL) for their leadership in introducing companion legislation to the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019. (kidneyfund.org)
  • Schlauderaff A, Boyer K C (May 09, 2019) An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices. (cureus.com)
  • Some of the highest prices include orphan drugs Lumizyme at $630,159 per patient in 2015, and Zolgensma at $2.1 million for a single-dose treatment in 2019. (wikipedia.org)
  • The Generic Drug User Fees for Fiscal Year 2019 have been published. (fda.gov)
  • The AARP's Washington headquarters, in a stunning reversal, has endorsed the current Medicare prescription drug plan. (citizen.org)
  • The legislation also would eliminate the so-called "doughnut hole" coverage gap -- or the gap in coverage under which Medicare beneficiaries are responsible for annual drug costs between $2,250 and $5,100. (californiahealthline.org)
  • Hillary Rodham Clinton (D-N.Y.) and Frank Lautenberg (D-N.J.), Medicare beneficiaries will no longer have to "rely on a bewildering array of private plans to meet their need for drugs," Kennedy said, adding, "In large cities and small rural areas, from Maine to California, to Alaska and Hawaii, Medicare will be there for every senior who wants it. (californiahealthline.org)
  • The bipartisan Senate legislation would cap what Medicare beneficiaries pay out of pocket for medicines and require drugmakers to pay rebates to Medicare if they hike prices above the inflation rate. (ibj.com)
  • The more ambitious House Democratic bill would build on the Senate's foundation but also authorize Medicare to negotiate prices for the costliest drugs. (ibj.com)
  • Bennet is backing the Senate compromise and also pursuing his own legislation allowing Medicare to negotiate drug prices. (ibj.com)
  • That is especially true of meaningful congressional action on drug pricing, since the expected vehicle for that was the Medicare extenders. (law360.com)
  • That means that any additional action on Medicare extenders and any action at all on drug pricing might wait until the lame-duck session after the Nov. 3 election, which gives a short window to work on a limited number of bills. (law360.com)
  • We are generally supportive of the policies in the Prescription Drug Pricing Reduction Act that would reduce beneficiary out‐of‐pocket costs, improve access and price transparency, and increase market competition in the Medicare program. (beckersasc.com)
  • If physician practices can no longer afford to administer these drugs, this policy is likely to force patients to seek care in the more expensive and less convenient hospital setting, where Medicare and patients pay dramatically more for drug administration. (beckersasc.com)
  • The STAR Act is the consolidated product of four House bills aimed at bringing transparency to drug price hikes and high launch prices, required reporting of product samples under the Physician Payments Sunshine Act (Sunshine Act), accountability by pharmaceutical benefits managers (PBMs), and accurate drug price reporting to the Medicare program. (morganlewis.com)
  • Reporting of ASPs Under Medicare Part B - Current law requires that most but not all manufacturers report the average sales price (ASP) for physician-administered drugs covered under Medicare Part B to HHS. (morganlewis.com)
  • When passed, S. 3353 and H.R. 5534 will extend Medicare coverage of immunosuppressive drugs for kidney transplant patients for the life of the transplant for Medicare patients under age 65. (kidneyfund.org)
  • This bill is a game-changer for those Americans who are fortunate enough to receive a kidney transplant but who stand to lose Medicare coverage for the immunosuppressive drugs after three years," said LaVarne A. Burton, AKF president and CEO of AKF, the nation's leading nonprofit working on behalf of the 37 million Americans living with kidney disease. (kidneyfund.org)
  • If they stop taking immunosuppressive drugs, their transplanted kidney will fail, and they will again need dialysis to stay alive, at which point they again become eligible for Medicare. (kidneyfund.org)
  • NEW YORK , Jan. 6, 2020 /PRNewswire/ -- "New legislation introduced today to extend Medicare coverage of immunosuppressive drugs for kidney transplant patients will not only save lives but save taxpayers money. (ptcommunity.com)
  • See Bobbie's story to learn how a lack of Medicare coverage for immunosuppressive drugs affects her family. (ptcommunity.com)
  • Health Care Policy and Marketplace Review: Medicare Drug Negotiation Legislation and a Drug Reimportation Bill--Will They Be Merged? (blogspot.com)
  • Earlier posts on the Medicare Part D drug negotiation issue. (blogspot.com)
  • Of its many provisions, two aim to reduce the burden of prescription drugs, both relating to the Medicare Part D coverage gap . (wikipedia.org)
  • With recent rulings by Medicare, we are in imminent danger of losing access to both of these drugs. (blogspot.com)
  • This report provides an analysis of how the cost-sharing and premium provisions under the Prescription Drug and Medicare Improvement Act of 2003 (S. 1) and the Medicare Prescription Drug and Modernization Act of 2003 (H bill would affect the amount that a beneficiary would pay annually for prescription drugs. (unt.edu)
  • This report examines these proposals as well as the "Medicare Rx Drug Benefit and Discount Act of 2003," which was introduced by Representative Charles Rangel, the ranking member of the House Ways and Means Committee. (unt.edu)
  • Improving Access to Drugs for Medicare Beneficiaries: Can State Law Help? (rand.org)
  • Although elderly Medicare beneficiaries account for more than a third of the nation's pharmaceutical expenditures, the Medicare program currently offers no prescription drug coverage. (rand.org)
  • Two-thirds of Medicare beneficiaries have some type of prescription drug coverage through employer-sponsored or privately purchased supplemental ("Medi-Gap") insurance. (rand.org)
  • Federal policymakers have proposed options ranging from providing comprehensive drug coverage under Medicare to subsidizing supplemental insurance policies that will cover medications. (rand.org)
  • Meanwhile, a number of states have enacted their own legislation requiring that Medicare beneficiaries be allowed to purchase drugs at reduced cost. (rand.org)
  • The doctors now say that when Medicare changed the formula, it engineered a new approach that is leaving many physicians in deep debt for the drugs they have to buy - a problem that has worsened as a string of pricey new biologics has become available. (managedcaremag.com)
  • Alcoholism and Drug Addiction Institutions Order 1986: revoked, on 21 February 2018, by section 122(2) of the Substance Addiction (Compulsory Assessment and Treatment) Act 2017 (2017 No 4). (legislation.govt.nz)
  • On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA) , which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2022. (fda.gov)
  • Newswise - WASHINGTON, D.C. - The American Hospital Association (AHA), American Society of Anesthesiologists (ASA), American Society of Clinical Oncology (ASCO), ASHP (American Society of Health-System Pharmacists), and the Institute for Safe Medication Practices (ISMP) announced their strong support for the Mitigating Emergency Drug Shortages (MEDS) Act, introduced today by Senators Susan Collins (R-ME) and Tina Smith (D-MN). (newswise.com)
  • Severe and critical drug shortages have become the norm for the nation's healthcare system. (newswise.com)
  • The MEDS Act provides increased authority for the U.S. Food and Drug Administration (FDA), enhanced manufacturing reporting requirements, and new market-based incentives to help mitigate the risks drug shortages pose to both our patients and the healthcare system. (newswise.com)
  • The five organizations jointly convened a summit on drug shortages in November 2010 and worked together to build support for drug shortage provisions included in the 2012 FDA Safety and Innovation Act (FDASIA). (newswise.com)
  • Over the past decade, America's hospitals and health systems have experienced far too frequent shortages of widely used drugs that are absolutely crucial to patient care and public health," said AHA Executive Vice President Tom Nickels. (newswise.com)
  • The AHA thanks Senators Susan Collins and Tina Smith for their bipartisan commitment to tackling the issue of drug shortages by introducing today's legislation. (newswise.com)
  • We support this legislation, which gives the FDA greater authority to prevent or mitigate shortages before they even begin. (newswise.com)
  • The drug shortage provision language should improve patient safety by creating a communication framework to reduce shortages of life-saving drugs and give patients and physicians early warning of impending shortages so that they may adjust treatments accordingly. (votesmart.org)
  • Across the country, patients and their doctors are facing shortages of critical, life-saving drugs," said Rooney. (votesmart.org)
  • By including our legislation in the bill approved today, the Energy and Commerce Committee has taken an important step toward reducing drug shortages and saving lives. (votesmart.org)
  • Recent data from the University of Utah Drug Information Service showed that 2011 had 56 more incidents of drug shortages than 2010, with a total of 211 life-saving medications suddenly unavailable. (votesmart.org)
  • But early reporting to the Food and Drug Administration (FDA) has recently proven to go a long way towards addressing these shortages and protecting patients. (votesmart.org)
  • and * Authorize the GAO to conduct a study to examine the causes of drug shortages and issue recommendations on how to prevent or alleviate a drug shortage. (votesmart.org)
  • It will also ensure that overlapping red tape does not impose dramatic costs on patients in the form of higher prescription drug costs or potential drug shortages. (thehill.com)
  • In addition to his interests in constitutional law and legislation, Ruger also teaches and writes in the area of health law and pharmaceutical regulation. (upenn.edu)
  • A correction has been made in regulation 15 under section 25(1)(j)(iv) of the Legislation Act 2012. (legislation.govt.nz)
  • Below, we discuss the past six months' developments in the regulation of both drugs and devices. (gibsondunn.com)
  • He said his organization hasn't taken an official stand yet on Sanders' price control proposal, but they support action to rein in drug costs. (healthline.com)
  • The organization notes that taxpayers invested more than $200 million to help research the drug. (healthline.com)
  • Chairing the meeting, Javaid Hassan Beigh told the Controller of Drug and Food Control Organization to submit a comprehensive report on the number of drug samples lifted by the organization from various areas of the state for testing within three days. (medindia.net)
  • Passage of the legislation „may mean that these drugs come onto the market without the testing necessary to make sure they are safe and effective," said Paul Winters, a spokesman for the Biotechnology Industry Organization, or BIO, a Washington-based group that represents makers of brand-name biotech drugs. (bbj.hu)
  • First, the organization and coordination of Federal drug control efforts. (wikipedia.org)
  • The price controls would be implemented by federal agencies and federally funded nonprofits before they granted manufacturers exclusive rights to produce drugs, vaccines, and other healthcare products. (healthline.com)
  • The legislation includes key policy recommendations long supported by the five healthcare organizations, which have worked collaboratively on drug shortage prevention efforts since 2010. (newswise.com)
  • She said the nation has over the years put in place several policies and measures to ensure drug security and improved healthcare delivery in the country, adding that some of these measures include a National Drug Policy which is targeted amongst other objectives to make available at all times to the Nigerian populace adequate supplies of drugs that are effective, affordable, safe and of good quality. (thisdaylive.com)
  • Completing a challenge issued to the legislature in his State of the State address last month and continuing his most aggressive, innovative campaign in the nation against drug addiction, Governor Christie signed into law today his life-saving healthcare reform that will guarantee insurance coverage for people to access immediate treatment and to limit initial opioid prescriptions. (drugfreenj.org)
  • It bears mentioning that none of this would be happening-drugs would be cheaper, Price would be investing in Waffle Houses and Shkreli would be torrenting rare Wu-Tang cuts-if we had single-payer healthcare. (hightimes.com)
  • 1997 ) Legislation and drug trials. (bmj.com)
  • The two EU agencies have worked closely together since 1997 when they began exchanging information on, and assessing the risks of, new synthetic drugs in Europe ( 3 ). (europa.eu)
  • 3 ) 1997 Joint action on the information exchange, risk assessment and control of new synthetic drugs. (europa.eu)
  • The Drug Free Communities Act of 1997 authorized the Office of National Drug Control Policy to carry out a national initiative that awards federal grants directly to community coalitions in the United States. (whitehousedrugpolicy.org)
  • Senator Bernie Sanders is backing two pieces of legislation that would introduce price controls and allow drug imports from Canada. (healthline.com)
  • Consumer groups welcome the pieces of legislation. (healthline.com)
  • Ayotte, a Republican, is co-sponsoring several pieces of legislation related to drug addiction treatment, including one that would direct the federal government to develop a strategy to help infants diagnosed with newborn withdrawal. (washingtontimes.com)
  • This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. (govtrack.us)
  • Drug-induced homicide laws may fulfill an instinct for retribution, but accomplish nothing with respect to reducing demand for drugs or preventing deadly drug overdoses. (baltimoresun.com)
  • Every year, thousands of Canadians die of drug overdoses from misused prescription drugs such as opioids, benzodiazepines and stimulants," said lead author Tara Gomes , a scientist at the Li Ka Shing Knowledge Institute of St. Michael's Hospital. (healthcanal.com)
  • Five states, New York, Illinois, Washington State, New Mexico, and Connecticut, have already enacted Good Samaritan laws for drug overdoses and similar measures are currently pending in several others. (drugpolicy.org)
  • Four people die a day in Ohio from prescription drug overdoses. (blogspot.com)
  • In Ohio, unintentional drug overdoses surpassed motor vehicle crashes and suicide as the leading cause of injury death in Ohio. (blogspot.com)
  • Arkansas' first outdoor entertainment district will open Wednesday, and the state Department of Correction can restart its search for the drugs needed to execute prisoners on death row. (arkansasonline.com)
  • The Arkansas Department of Correction will be able Wednesday to begin anew its search for the proper drugs to carry out executions as a result of Act 810, which allows the state to keep secret nearly all information about the drugs it obtains. (arkansasonline.com)
  • This piece of legislation is an intervention," she said, adding "Do you want help for yourself, and do you want help for the baby who is inside your womb, or not? (theatlantic.com)
  • It would be a mammoth piece of legislation , targeting nearly every area of the health care industry for reform, including surprise medical bills, prescription drugs, price transparency, public health and health information. (knpr.org)
  • Senate Bill 968 by state Sen. Lois Kolkhorst , R-Brenham, is a sweeping piece of legislation passed in the final days of the legislative session that includes a clause banning businesses from requiring proof of the vaccine from their customers. (robertscottbell.com)
  • The Health and Safety at Work Act is the main piece of legislation for workplace safety and health in Great Britain. (cansfordlabs.co.uk)
  • The article was updated April 1, 2020, to reflect that President Trump signed the legislation. (pewtrusts.org)
  • A Gallup-West Health poll finds that 66 percent of adults don't believe the Trump administration has made any progress, or very much progress, in limiting the rising cost of prescription drugs. (ibj.com)
  • A bipartisan trio of senators urged the Office of Management and Budget to take administrative action to lower prescription costs - while 36 House Democrats asked President Trump to consider using FDA user fee legislation as a vehicle to cut drug prices. (fdanews.com)
  • There was a time that the high cost of prescription drugs was a big Donald Trump talking point. (hightimes.com)
  • Trump would "give consumers more options" by allowing Americans to import cheap generic drugs from other countries. (hightimes.com)
  • Magically, Trump stopped talking about pricey prescription drugs shortly after he was elected, as the LA Times observed late last year. (hightimes.com)
  • Reports from both the Sunshine State News and Florida Politics suggest that Pam Bondi is the next logical selection for director of the Office of National Drug Control Policy (ONDCP) due to her present connection with Trump as part of his Commission on Combating Drug Addiction and the Opioid Crisis . (hightimes.com)
  • Programs to ensure immediate treatment referral in hospitals and to provide medically-supervised spaces for drug users to consume drugs have been shown to prevent fatalities, increase public safety and increase uptake into addiction treatment. (baltimoresun.com)
  • The bill would reverse the state's earlier abandonment of the provision in favor of a more compassionate approach to drug addiction and pregnancy. (theatlantic.com)
  • He said drug and alcohol screenings play a role in public safety - with the tests sometimes administered to bus and truck drivers, medical professionals or heavy-equipment operators - and are commonly used as part of addiction-treatment programs. (sltrib.com)
  • He also questioned why the proposed penalties for duping a drug test or distributing fake urine are so high if the intent of the legislation is to encourage individuals to honestly complete addiction treatment. (sltrib.com)
  • Pursuant to the Alcoholism and Drug Addiction Act 1966 , His Excellency the Governor-General, acting by and with the advice and consent of the Executive Council, hereby makes the following order. (legislation.govt.nz)
  • This order may be cited as the Alcoholism and Drug Addiction Institutions Order 1986. (legislation.govt.nz)
  • Each of the hospitals named in the Schedule is hereby certified as an institution under the Alcoholism and Drug Addiction Act 1966 . (legislation.govt.nz)
  • revoked , on 1 November 1996 , by clause 2(2) of the Alcoholism and Drug Addiction Institutions Order 1996 (SR 1996/291). (legislation.govt.nz)
  • This is a reprint of the Alcoholism and Drug Addiction Institutions Order 1986 that incorporates all the amendments to that order as at the date of the last amendment to it. (legislation.govt.nz)
  • Exchanging information on new psychoactive substances and abused medicines is enhanced today, thanks to an amended working arrangement signed in Lisbon by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and the European Medicines Agency (EMA) ( 1 ). (europa.eu)
  • The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is the reference point on drugs and drug addiction information in Europe. (europa.eu)
  • TRENTON - Senate Health Committee Chairman Joseph F. Vitale today announced that he is sponsoring with Senate President Steve Sweeney and Senate Minority Leader Tom Kean Jr. legislation that aims to address the addiction crisis in New Jersey. (drugfreenj.org)
  • I want to thank Senator Sweeney for his ongoing support and look forward to moving forward with this legislation together as we join efforts to address the addiction crisis gripping our state. (drugfreenj.org)
  • Specifically, the practitioner would discuss the risks of addiction and overdose, alternative treatments that may be available, the risks of developing a physical or psychological dependence on the controlled dangerous substance, and the dangers of taking opioid drugs with alcohol or other medications. (drugfreenj.org)
  • Several drug abuse and addiction-related questions were asked by subcommittee members (as well as the Chairman of the full committee, Congressman Hal Rogers (R-KY). (drugabuse.gov)
  • Synthetic drugs are produced by modifying the chemical structure of existing illicit substances, with the goal of mimicking those substances� effects while evading criminal prosecution. (naag.org)
  • Earlier this month, Sanders introduced a rule change to the 1938 Federal Food, Drug, and Cosmetic Act. (healthline.com)
  • The Food and Drug Administration currently is unable to approve generic copies of expensive biotech drugs. (redorbit.com)
  • The U.S Senate on Thursday passed the Over-the-Counter Hearing Aid Act as part of the Food and Drug Administration Reauthorization Act on a vote of 94-1. (drugstorenews.com)
  • Under the regulatory system established nearly 50 years ago, the Food and Drug Administration (FDA) has not been able to quickly respond to safety concerns or keep pace with innovation. (pewtrusts.org)
  • The Verifying Authority and Legality in Drug (VALID) Compounding Act will give the Food and Drug Administration (FDA) clear, new authority to oversee compounding pharmacy practices throughout the country. (drugs.com)
  • The Food, Drug, and Cosmetic Act , in M AJOR A CTS OF C ONGRESS (2004). (upenn.edu)
  • The Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Professor Christiana Mojisola Adeyeye has called on the federal government not to put drugs and poisons on Concurrent List, nothing that this will not only cause multiplicity of drug legislation, but will lead to chaotic distribution. (thisdaylive.com)
  • The new law will give the Food and Drug Administration (FDA) the resources to establish an active surveillance system to detect adverse drug effects. (ssrn.com)
  • The bill also allows the Food and Drug Administration to regulate what goes into tobacco products. (drugs-forum.com)
  • 2009) and has served on a range of committees and working groups for the Food and Drug Law Institute and the Global Self-Care Federation. (fdli.org)
  • Fill out the form below to receive emails highlighting our upcoming programs, early registration savings, and engagement opportunities for the food and drug law community. (fdli.org)
  • US law allows the Food and Drug Administration to approve generic versions of conventional drugs, made mostly through chemical synthesis, after patents expire. (bbj.hu)
  • Setting New therapeutics approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Health Canada between 2000 and 2010. (bmj.com)
  • This is the first study to quantify the potential clinical impact of reciprocal approval legislation, based on prior approval histories by the Food and Drug Administration (FDA) and other regulatory bodies. (bmj.com)
  • In the USA, a new drug is approved when the Food and Drug Administration (FDA) reviews the manufacturer's application to the agency and determines that the drug meets appropriate safety and efficacy standards. (bmj.com)
  • Hundreds of parents across America have been pressured to put their school-aged children onto cocaine-like stimulants or antidepressants for which the Food and Drug Administration (FDA) has just ordered a "black box label" warning of the drugs' high risk of causing suicide among children and adolescents. (laleva.org)
  • The draft bill, discussed with the Food and Drug Administration (FDA) and industry officials last month, would close loopholes in the supply chain and aim to prevent counterfeit drugs from reaching consumers. (thehill.com)
  • Book about US food packaging legislation? (ifsqn.com)
  • I am looking for a good book about US/FDA food packaging legislation. (ifsqn.com)
  • The precursor to the Food and Drug Administration (FDA) first emerged in 1906, when President Theodore Roosevelt signed the Pure Food and Drugs Act, which prohibited interstate commerce of misbranded and adulterated food and drugs. (cureus.com)
  • In 1938, the Federal Food, Drug, and Cosmetic Act ("FD&C Act") authorized the FDA to regulate medical products. (cureus.com)
  • The Food and Drug Administration approved the drug from Biogen based on study results showing it seemed "reasonably likely" to benefit Alzheimer's patients. (robertscottbell.com)
  • The Food and Drug Administration Safety and Innovation Act of 2012 ( FDASIA ) is a piece of American regulatory legislation signed into law on July 9, 2012. (govtrack.us)
  • It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. (govtrack.us)
  • To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies. (govtrack.us)
  • President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. (govtrack.us)
  • On July 9, 2012, GDUFA was signed into law by the President as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). (fda.gov)
  • In June 1938, Franklin D. Roosevelt signed into law a new Food, Drug, and Cosmetic Act, the first major legislation regulating these industries since the 1906 Wiley law. (sirsi.net)
  • The U.S. Department of Justice ("DOJ") and the U.S. Food and Drug Administration ("FDA"), in particular, pursued drug and device companies-and, in some instances, individual executives at those companies-for a variety of alleged misconduct. (gibsondunn.com)
  • As in past updates, we begin with an overview of government enforcement efforts against drug and device companies under the False Claims Act ("FCA"), the Federal Food, Drug, and Cosmetic Act ("FDCA"), and other laws. (gibsondunn.com)
  • Late last month, the federal government announced that the drug was helping and the US Food and Drug Administration gave remdesivir an emergency use authorization to treat Covid-19. (wtop.com)
  • Patients are struggling so much right now with skyrocketing drug prices," Ben Wakana, executive director of Patients for Affordable Drugs, told Healthline. (healthline.com)
  • In fact, Patients for Affordable Drugs is launching a campaign today to demand that Novartis provide a fair price for its new cancer drug . (healthline.com)
  • ASA is proud to endorse this important legislation that will help ensure critical drugs are available for procedures so physician anesthesiologists can provide patients safe, timely care," said ASA President Linda J. Mason, M.D., FASA. (newswise.com)
  • We believe this legislation is a significant step in addressing our nation's drug shortage crisis, and supports our goal of ensuring patients have reliable access to the medications they need, when they need them. (newswise.com)
  • In his veto message, Brown said "patients with life-threatening conditions should be able to try experimental drugs" but that proposed changes to federal policies would streamline access to such drugs. (sacbee.com)
  • WASHINGTON - Legislation to protect doctors and patients in states with medical marijuana laws from federal prosecution was introduced today by U.S. Sen. Cory Booker and two of his colleagues. (nj.com)
  • The agency's complicated system also made it difficult for FDA to protect patients from drugs that were shown to be unsafe or ineffective after approval of the original monograph. (pewtrusts.org)
  • The value of this system could be greatly improved by expanding access to physicians to help them understand patients' prescribing history and identify potential drug-seeking behavior at the time of writing a prescription. (healthcanal.com)
  • Counting drug coupons as part of a drug's added sales price could tie the hands of independent clinicians trying to ensure patients get access to affordable and effective care options, said Michael Weinstein, MD. (beckersasc.com)
  • Putting these signals in the labeling or on an agency website can permit physicians to make a more informed judgment in advising patients about the balance of risks and benefits that a drug has. (ssrn.com)
  • In many instances, no safe alternatives to these drugs exist, leaving patients with an increased risk of side effects and adverse drug interactions. (votesmart.org)
  • The White House held an event featuring patients, several House committees have held hearings, and bipartisan groups in the House and Senate have proposed legislation, including a bill from Sens. (knpr.org)
  • Transplant patients must take these drugs for as long as their transplanted kidney is functioning, and this bill will help ensure that no one has to stop taking these drugs-and go back on dialysis-because they cannot afford them. (kidneyfund.org)
  • This bill is not only the right thing to do for patients, but it is also fiscally responsible legislation that will save American taxpayers money over the long term. (kidneyfund.org)
  • Conclusions If enacted, reciprocal approval legislation would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms. (bmj.com)
  • Securing the supply chain through this bill will help ensure that counterfeit or stolen drugs do not enter the supply chain and harm patients," said Rep. Joe Pitts (R-Pa. (thehill.com)
  • The bill also calls for clear and direct discussions with patients, or a patient's parent or guardian if he or she is a minor, about the risks associated with the schedule II controlled dangerous substances or any other opioid drug being prescribed prior to issuing the initial prescription and at certain stages during the course of treatment. (drugfreenj.org)
  • We have written before on the potential value of radioimmunotherapy (RIT) drugs such as Bexxar and Zevalin to CLL patients. (blogspot.com)
  • The $100 million government-backed study, presented at the American Heart Association (AHA) meeting in Philadelphia, is the largest yet to look at whether procedures to restore normal blood flow in patients with stable heart disease offers an added benefit over more conservative treatment with aspirin, cholesterol-lowering drugs and other measures. (yahoo.com)
  • Researchers have finally published the data that led the federal government to recommend the use of the antiviral drug remdesivir in very ill coronavirus patients, and they say the drug alone will not be enough to help patients. (wtop.com)
  • Other teams are already combining antiviral drugs , including remdesivir, with immune modulating drugs in coronavirus patients. (wtop.com)
  • The study's findings were considered significant because it was the first double-blind, placebo-controlled trial to test the drug in patients. (wtop.com)
  • That means some patients got no drug, and neither patient nor doctors knew who was getting the real treatment. (wtop.com)
  • Patients who needed oxygen appeared to benefit the most from the drug, the researchers reported. (wtop.com)
  • New rules limiting the use of anemia drugs for cancer patients have added to the price pressure. (managedcaremag.com)
  • Grogan said the administration is working to line up Republican support for the Senate bill while trying to sweeten its impact by plowing more of the government's savings from reduced drug prices into benefits for seniors. (ibj.com)
  • Because the extenders were included in the Phase 3 legislation that passed the Senate and that the House is expected to pass tomorrow, that vehicle is now gone until November. (law360.com)
  • The Prescription Drug Pricing Act, which the Senate will consider this fall, includes a provision that would require drugmakers to include the value of drug coupons when calculating a drug's average sales price. (beckersasc.com)
  • Trenton-Next week, the New Jersey Senate Judiciary Committee will consider the Good Samaritan Overdose Response Act (S851/A578), which provides limited legal protection for those who witness a drug overdose and summon medical assistance. (drugpolicy.org)
  • chairman of the Senate health committee, introduced legislation to address health care issues such as surprise medical bills and high drug costs. (knpr.org)
  • It would use an independent arbitrator to settle disputes between insurance plans and providers and set a standard benchmark for physician pay, ideas that have popped up in other draft legislation circulating in the House and Senate. (knpr.org)
  • We urge both the Senate and the House of Representatives to quickly move ahead with this common-sense legislation that saves lives and money. (kidneyfund.org)
  • Lawmakers in the US House and Senate introduced legislation that would for the first time routinely allow copies of medicines made using biotechnology. (bbj.hu)
  • I will review the language provided today in the governor's draft legislation and determine if any other priorities that I have worked on with my colleagues in the Senate need to be added," said Senator Vitale (D-Middlesex). (drugfreenj.org)
  • The new legislation, including bills introduced in the state Senate and House, would allow pharmacists to administer those vaccines to children ages 7 years and older as well. (drugstorenews.com)
  • The excuse Republicans on a Senate committee gave, as the plan died on a 13-10 party-line vote, was that drugs bought from Canada are not safe. (hightimes.com)
  • CMS Administrator Mark McClellan testified that enrollment in the drug benefit is "off to a strong start," adding that more than 25 million beneficiaries have drug coverage, many more are enrolling each week and costs are lower than expected. (californiahealthline.org)
  • The study, published today in CMAJ Open , evaluated the impact the Narcotics Safety and Awareness Act and the Narcotics Monitoring System had on the rate of dispensing of monitored drugs among public drug plan beneficiaries in Ontario. (healthcanal.com)
  • Federal Trade Commission staff, in response to a request for comment from New York State Senator James L. Seward, stated that consumers are likely to be harmed by proposed state legislation that would limit a health plan's ability to steer beneficiaries to a lower cost mail order provider of prescription drugs. (drugs.com)
  • In addition, this report gives examples of how annual cost-sharing would differ for beneficiaries with various levels of total prescription drug spending in 2006 under the plans. (unt.edu)
  • These beneficiaries have high out-of-pocket drug expenditures, and those on modest incomes tend to forgo necessary medications. (rand.org)
  • Public Disclosure of Drug Discounts by PBMs - Beginning January 1, 2020, aggregate rebates, discounts, and other price concessions by PBMs reported under current law would be posted to the HHS website for public access. (morganlewis.com)
  • While the new law aims to address the safety issues raised by Vioxx, it basically is a compromise that needed to be signed to renew the user fees that fund a major part of FDA's drug regulatory program. (ssrn.com)
  • FDA's latest enforcement action, a notice of which will be published in the Federal Register on October 1, 2007 (a pre-publication version is available here ), wraps up the Agency's previous conclusions made under the Drug Efficacy Study Implementation (" DESI ") program for certain pre-1962 FDA-approved hydrocodone drug products, which were last addressed in 1982 Federal Register notices. (fdalawblog.net)
  • FDA's actions are consistent with the Agency's June 2006 Compliance Policy Guide , in which FDA announced its enforcement priorities for marketed unapproved drugs. (fdalawblog.net)
  • FDA's action comes on the heels of an article on CNN.com and an editorial in the Wall Street Journal critical of the Agency's handling of marketed unapproved drugs. (fdalawblog.net)
  • Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, met with lawmakers at the April meeting and urged for the more rigorous standards. (thehill.com)
  • GDUFA aims to put FDA's generic drug program on a firm financial footing and ensure timely access to safe, high-quality, affordable generic drugs. (fda.gov)
  • GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA's generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications. (fda.gov)
  • Sanders has been pushing two proposals that he says will help slash the skyrocketing costs of pharmaceutical drugs. (healthline.com)
  • The amendment would require pharmaceutical companies to charge fair prices for drugs that were developed with the assistance of taxpayer money. (healthline.com)
  • and allow HHS to negotiate drug prices with pharmaceutical companies. (californiahealthline.org)
  • The Generic Pharmaceutical Association, a Washington-based trade group that represents the generic drug industry, heralded the move. (drugstorenews.com)
  • A mechanism should be put in place for rationalization of drug prices, especially the vaccines, to prevent common people from being fleeced by the "greedy" pharmaceutical companies," said Javaid Hassan Beigh. (medindia.net)
  • A systematic review of all new drugs evaluated in 2011-2016 within a health care profession-driven resource prioritization process, with a market approval based on prospective case series, and a reimbursement decision by the Swedish Dental and Pharmaceutical Benefits Agency (TLV). (arctichealth.org)
  • OSSINING - Governor Andrew M. Cuomo signed the Drug Take Back Act on Tuesday, legislation that will go a long way in protecting the state's waterways from pharmaceutical contamination. (riverkeeper.org)
  • Pharmaceutical drugs are the only major health care service in which the producer is able to set prices with little constraint, according to Peter Bach from the Health Outcomes Research Group, Memorial Sloan Kettering Cancer Center , New York and Steven Pearson from the Institute for Clinical and Economic Review, Boston. (wikipedia.org)
  • While massive mergers and pharmaceutical pricing dominated industry headlines in 2015, the U.S. Government continued to shape the drug and device industries through enforcement actions and other regulatory activities this past year. (gibsondunn.com)
  • While the federal government considers various ways to make prescription drugs more affordable for this population, a number of states, including California, have passed laws creating pharmaceutical assistance programs. (rand.org)
  • Increases transparency to the public by mandating that compounded drugs be labeled to ensure that recipients know that the drugs have not been tested for safety or effectiveness, publishing a "Do Not Compound" list of unsafe or ineffective drugs, and reporting of bad reactions to compounded drugs or any drug that poses a safety risk. (drugs.com)
  • That would limit high launch prices for new drugs, not just price increases. (ibj.com)
  • Drug Manufacturer Price Transparency - The STAR Act provides that if the price of a drug increases by more than 10% or $10,000 over one year, or 25% or $25,000 over three years, or if the manufacturer launches a new drug at or above $26,000, the manufacturer must submit a "justification" to HHS with cost information beginning in 2021. (morganlewis.com)
  • While the "Prohibition on Mandatory Medication Amendment" will help prevent some of psychiatry's propensity to drug all normal childhood behavior, many charge that the spurious sounding "Freedom Commission on Mental Health" and its recommendations will open another door to dangerous conditioning leading to massive increases in psychotropic drugging of a new generation. (laleva.org)
  • In addition, the Wall Street Journal article notes that "Congressional legislation [creating a special regulatory pathway for marketed unapproved drugs] will be introduced shortly. (fdalawblog.net)
  • GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry to address a growing number of regulatory challenges. (fda.gov)
  • analysis and prevention of adverse drug reactions with MedDRA, industry experiences and global regulatory coverage of developments. (smi-online.co.uk)
  • The cardiovascular risks for Vioxx found in tests after it was on the market were known for some time before a warning was added to the label following extensive negotiations between the agency and the drug sponsor. (ssrn.com)
  • These signals include undertakings by the sponsor for additional follow-up studies on emerging risks and the factual findings about serious risk made in medical reviews of clinical studies for drugs on the market. (ssrn.com)
  • The paper also examines the IOM recommendations that there be a moratorium on consumer advertisements for newly-approved drugs because the risks are not fully known. (ssrn.com)
  • The extent to which drug risks need to be disclosed is also of key importance for product liability suits. (ssrn.com)
  • In addition to the legislation, the Health Department has launched an education campaign warning residents about the risks of the drugs and encouraging stores to voluntarily stop selling them. (dailypress.com)
  • FDA also notes additional risks, such as medication errors because of "confusion based on similarity between the proprietary names of unapproved hydrocodone-containing antitussive products and other drug products. (fdalawblog.net)
  • These enforcement priorities include taking action on drugs with potential safety risks. (fdalawblog.net)
  • Utahns could face a misdemeanor for using fake urine, someone else's urine or their own stored urine to beat an alcohol or drug-screening test under legislation sponsored by Rep. Steve Eliason, R-Sandy. (sltrib.com)
  • State v. Siegmeister, 577, 256 A.2d 319 (1969) - Prosecution for operation of motor vehicle under influence of alcohol or drugs is quasi-criminal and state has burden of establishing guilt beyond reasonable doubt. (norml.org)
  • Employers also need to test employees to make sure they aren't affected by drugs or alcohol. (cansfordlabs.co.uk)
  • Testing your workers for drugs and alcohol is important for ensuring the safety of their co-workers. (cansfordlabs.co.uk)
  • In addition, the House Committee on Oversight and Government Reform announced today they are launching an investigation into the price for drugs that treat multiple sclerosis. (healthline.com)
  • The chairman of the Energy and Commerce Committee on Monday called on President Barack Obama to speed up legislation that would approve the use of generic biotech drugs. (redorbit.com)
  • PDUFA, including the drug shortage legislation, passed the Committee unanimously. (votesmart.org)
  • After the menace due to the selling of poisonous drugs in the Jammu & Kashmir state, the Legislation Committee reviewed the functioning of the Health and Medical Education Department in the state. (medindia.net)
  • WASHINGTON, DC- Representative Eliot L. Engel (D-NY), the leading Democrat on the House Foreign Affairs Committee, and Representative Matt Salmon (R-AZ), Chairman of the Foreign Affairs Subcommittee on the Western Hemisphere, today introduced legislation aimed at reducing drug trafficking in the Western Hemisphere. (house.gov)
  • The Energy and Commerce Subcommittee on Health voted on Wednesday morning to send the legislation to the full committee for consideration, but not before raising some apprehension. (thehill.com)
  • In 1970, President Nixon recruited the director of the National Heart and Lung Institute, Dr. Theodore Cooper, to chair the Cooper Committee to evaluate the need for medical device legislation. (cureus.com)
  • The Cooper Committee recommended new specific legislation for devices in a risk-stratified manner [1] . (cureus.com)
  • Good clinical practice and ethics in European drug research / edited by Peter Bennett on behalf of the European Ethical Review Committee and the European Foundation for Good Clinical Practice. (who.int)
  • Rep. Henry Waxman, D-Calif. praised the President for his approval of generic biologics as a part of the fiscal year 2010 budget, but he urged the President to take steps that would prepare for and even begin to approve biotech drugs in advance of legislation. (redorbit.com)
  • In March, Chairman Waxman introduced bipartisan bill H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act," which would give the FDA the ability to approve more affordable generic copies of biotech drugs. (redorbit.com)
  • According to the Associated Press, the Federal Trade Commission is expected to issue its report this week to determine the "competitive impact of a pathway for generic biotech drugs. (redorbit.com)
  • Generic biotech drugs could reduce prices by almost a third and cut into the profits of brand-name biotech companies such as Amgen Inc. and Genentech Inc., analysts said. (bbj.hu)
  • Without action, the manufacturers of these biotech drugs can continue to charge monopoly prices indefinitely," Senator Hillary Clinton, a Democrat from New York and presidential candidate, said at a news conference in Washington. (bbj.hu)
  • Biotech drugs hold great promise, but we break that promise when the costs push treatments out of reach. (bbj.hu)
  • Biotech drugs generated revenue of about $32.8 billion, 13% of the $251.8 billion in prescription sales to US pharmacies in 2005, according to IMS Health Inc., a research company in Fairfield, Connecticut. (bbj.hu)
  • Proponents of the legislation use the term „generics" for the biotech drugs they want to reproduce. (bbj.hu)
  • WASHINGTON - Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report. (drugstorenews.com)
  • SAN DIEGO - Early detection of a deadly brain infection that sometimes arises due to treatment of autoimmune disorders with immune-suppressing biotech drugs may improve survival, according to a new study. (drugstorenews.com)
  • It was drawn up in the light of newly applied EU legislation on pharmacovigilance designed to strengthen Europe's system for medicines safety. (europa.eu)
  • Depending on how long the [coronavirus] crisis continues, the rising cost of prescription drugs may once again become an important election issue, which could help build momentum to pass legislation prior to the election. (law360.com)
  • A report by the Congressional Budget Office (CBO) released this month estimated the Affordable and Safe Prescription Drug Importation Act would save U.S. consumers nearly $7 billion over the next 10 years. (healthline.com)
  • In a year already marked by a wide variety of congressional health care legislation, Sens. (knpr.org)
  • The H.R. 5210 legislation was passed by the 100th U.S. Congressional session and enacted into law by the 40th President of the United States Ronald Reagan on November 18, 1988. (wikipedia.org)
  • The other legislation Sanders is promoting is a bill that would allow Americans to buy prescription drugs from Canada and other countries. (healthline.com)
  • While Governor Hogan's bill includes a limited criminal immunity provision, we fear the mere imposition of a drug-induced homicide law will cause individuals to think twice about calling 911 regardless of potential immunity, wasting valuable minutes that often determine life or death. (baltimoresun.com)
  • Tennessee's legislature is preparing to give its approval to a bill that would criminalize some drug-addicted pregnant women, depending on the outcome of their pregnancy. (theatlantic.com)
  • The bill, if signed into law, would allow prosecutors to charge a woman with an "assaultive offense or homicide" if she takes illegal narcotics during her pregnancy, if "the child is born addicted, is harmed, or dies because of the drug. (theatlantic.com)
  • Although that added provision helped to moderate some state-based opposition to the bill, Salon notes that most major medical associations, including the American Medical Association and the American Academy of Pediatrics, believe that the measure would discourage women with drug addictions from seeking prenatal care (and therefore risk discovery) in the first place. (theatlantic.com)
  • I think it's critically important for the country for us to get a bill done-a drug-pricing bill is long overdue," said Bennet. (ibj.com)
  • Eliason said he was prompted to run the bill after reading about similar efforts in other states - such as Mississippi's so-called "Urine Trouble" bill - and after researching Utah's current statutes on defrauding drug tests. (sltrib.com)
  • Thanks to this bill … we will stop the spread of these dangerous drugs in our communities here in Baltimore,' Rawlings-Blake said. (dailypress.com)
  • If the bill is passed by the City Council, health inspectors could inspect stores for the drugs and confiscate them. (dailypress.com)
  • The legislation already has gained support from City Council members and two trade groups that represent the convenience stores and retailers that the bill could affect. (dailypress.com)
  • The trade group that represents convenience stores said it is still reviewing the legislation but that it would support the bill. (dailypress.com)
  • The FTC staff comment letter expressed concern that New York Assembly Bill 5502-B, if enacted, would reduce competition between retail and mail order pharmacies, leading to higher costs and, potentially, reduced access to prescription drugs for New York consumers. (drugs.com)
  • The bill would create an independent commission which would be charged with reviewing and evaluating U.S. policy regarding illicit drug supply reduction and interdiction in the Western Hemisphere. (house.gov)
  • Schroer's bill includes a Democratic amendment toughening penalties on date rape drugs. (missourinet.com)
  • Drug manufacturers, rather than the taxpayers, would foot the entire bill for implementing the program. (riverkeeper.org)
  • House Bill 93 will enhance the current Ohio Automated Rx Review System (OARRS)-which was established in 2006 to assist health care professionals in identifying drug-seeking behaviors-to provide additional oversight. (blogspot.com)
  • A new bill introduced by Senator Byron Dorgan (D-ND) and Olympia Snowe (R-ME), as well as Representative Rahm Emanuel (D-IL) and Jo Ann Emerson (R-MO) in the House, would establish the framework for wholesalers and retailers to purchase FDA-approved drugs from FDA-approved manufacturing facilities in foreign nations. (blogspot.com)
  • In addition, the bill would require the FDA to regulate the shipments of prescription drugs reimported (originally manufactured in the U.S.) back into the U.S for personal or commercial use. (blogspot.com)
  • It wouldn't surprise me to see this bill eventually merged with a compromise drug negotiation bill that focuses on the one-of-a-kind drugs the Snowe/Wyden bill is targeted on. (blogspot.com)
  • Working closely with the Governor's office on developing language for the bill, the legislation is the latest of many bills spearheaded by Senator Vitale in the fight against the opioid and heroin epidemic in New Jersey. (drugfreenj.org)
  • Some of the issues covered under the bill, which is currently being drafted, will include insurance benefits coverage for inpatient and outpatient treatment of substance use disorder, guidelines on pre-payment of medical expenses incurred during the first six months of treatment, and imposing limits on the supply of any opioid drug prescribed for acute pain. (drugfreenj.org)
  • Gov. Greg Abbott signs bill to punish businesses that require proof of COVID-19 vaccination Texas businesses that require customers to be vaccinated against COVID-19 will be denied state contracts and could lose their licenses or operating permits under legislation Gov. Greg Abbott signed into law Monday. (robertscottbell.com)
  • Our model bill is designed to spur discussion that helps inspire meaningful privacy legislation. (yahoo.com)
  • Intel's model data privacy bill aims to bring together policymakers and others in a transparent and open process that helps drive the development of actual data privacy legislation. (yahoo.com)
  • Specifically, this report provides background on how the cost-sharing and premium provisions under each bill would affect the amount that a beneficiary pays annually for prescription drugs. (unt.edu)
  • COLUMBUS -State Representative Danny Bubp (R-West Union) announced that legislation to address prescription drug abuse and strengthen oversight measures passed from the Ohio House of Representatives by a vote of 97-0. (blogspot.com)
  • Parliament passed on Monday amendments to drug legislation which will allow sales of some over-the-counter drugs outside of pharmacies, require drugmakers and drug importers to pay back to the state part of the subsidies on their products and introduce looser rules for opening pharmacies. (bbj.hu)
  • It also prohibits pharmacies from accepting drugs as gifts from producers. (bbj.hu)
  • The legislation includes support measures for smaller pharmacies in villages and towns paid for by larger pharmacies. (bbj.hu)
  • The House passed H.R. 1919 , the Safeguarding America's Pharmaceuticals Act of 2013, to monitor the movement of drugs through the chain, including manufacturers, distributors and pharmacies, creating new regulations for handling of drug products and notification rules concerning drugs potentially unsuitable for distribution. (drugstorenews.com)
  • WASHINGTON, D.C. - Today, Congressman Edward J. Markey (D-Mass.) announced legislation he plans to introduce tomorrow that will strengthen federal regulations for compounding pharmacies. (drugs.com)
  • The system also alerts pharmacists when they're dispensing prescriptions about potentially inappropriate drug-seeking behavior, such as conflicting filled prescriptions or other pharmacies that have dispensed a prescription. (healthcanal.com)
  • The staff concluded that, although the measure may seek to enhance consumers' ability to fill prescriptions at pharmacies of their choice, it would impede a fundamental element of consumer choice: healthy competition between retail and mail order pharmacies, which constrains costs and maximizes access to prescription drugs. (drugs.com)
  • The law will require that chain pharmacies provide free and convenient drug disposal, while other authorized collectors (e.g. independent pharmacies, local law enforcement) would have the option of participating. (riverkeeper.org)
  • This is also why many Americans, including relatives of Sen. Tim Kaine, who a lifetime ago was going to be Hillary Clinton's vice president, already buy drugs from other countries via online pharmacies. (hightimes.com)
  • Those who do not have other insurance coverage to cover their immunosuppressive drugs often cannot afford the cost, which is typically thousands of dollars each month. (kidneyfund.org)
  • The cost of paying for immunosuppressive drugs is a fraction of the cost of paying for dialysis," Burton noted. (kidneyfund.org)
  • Taking life-saving immunosuppressive drugs suppresses the body's ability to do this and helps prevent organ rejection. (ptcommunity.com)
  • Pursuant to section 37(1)(g) of the Misuse of Drugs Act 1975, His Excellency the Governor-General, acting on the advice and with the consent of the Executive Council, makes the following regulations. (legislation.govt.nz)
  • Similar legislation passed the House of Representatives unanimously on December 8, 2009 with a diverse group of 30 bipartisan cosponsors. (house.gov)
  • Manchester Police Chief David Mara said education should be a greater focus, with children being warned about prescription drug abuse at an earlier age. (washingtontimes.com)
  • Currently, 17 states, including Tennessee, consider drug use during pregnancy to be child abuse under civil child welfare statutes, according to the Guttmacher institute. (theatlantic.com)
  • Those attempts had a couple victories in the state courts: a South Carolina Supreme Court decision agreed that drug use during late pregnancy is criminal child abuse under state law. (theatlantic.com)
  • Even in Tennessee, officials have tried to prosecute pregnant women for drug abuse despite their explicit protection under the law. (theatlantic.com)
  • Drug toxicity is an adverse reaction of the body towards a drug that results as a side effect of a drug, reaction to a drug or drug abuse. (medindia.net)
  • New to the arrangement signed today is that the EMA will now inform the EMCDDA of any 'validated signals' ( 5 ) on the suspected side effects of medicinal products related to drug abuse. (europa.eu)
  • When enacted, it will combat the growing prevalence of prescription drug abuse deaths within the state of Ohio. (blogspot.com)
  • In 2009 Adams County was #1 and Brown County was #5 in the state of Ohio for prescription drug abuse deaths," stated Bubp. (blogspot.com)
  • This is a great day for this legislative body, the state of Ohio, and the victims of prescription drug abuse and their families," said Burke, a pharmacist and owner of Dave's Pharmacy in Marysville. (blogspot.com)
  • The Anti-Drug Abuse Act of 1988 established the creation of a drug-free America as a policy goal. (whitehousedrugpolicy.org)
  • and seek to reduce drug abuse, trafficking, and their consequences. (whitehousedrugpolicy.org)
  • Specifically, drug abuse is to be curbed by preventing young people from using illegal drugs, reducing the number of users, and decreasing drug availability. (whitehousedrugpolicy.org)
  • Such coalitions work to reduce substance abuse among adolescents, strengthen collaboration among organizations and agencies in both the private and public sectors, and serve as catalysts for increased citizen participation in strategic planning to reduce drug use over time. (whitehousedrugpolicy.org)
  • The Media Campaign Act of 1998 directed ONDCP to conduct a national media campaign for the purpose of reducing and preventing drug abuse among young people in the United States. (whitehousedrugpolicy.org)
  • In addition to in-person treatments, all prescription drugs used to treat substance abuse disorder shall be covered by a carrier without prior authorization or utilization management review. (drugfreenj.org)
  • Transcript, statements and video available at http://energycommerce.house.gov/press-release/suboversight-continues-its-review-growing-threat-prescription-drug-and-heroin-abuse . (drugabuse.gov)
  • Drugs of abuse / Simon Wills. (who.int)
  • The Anti-Drug Abuse Act of 1988 also offers several other amendments to the Act of 1986. (wikipedia.org)
  • Anti-Drug Abuse Act of 1986 Chemical Diversion and Trafficking Act Domestic policy of the Ronald Reagan administration Federal drug policy of the United States Hall, D: Administrative Law Bureaucracy in a Democracy 4th Ed., page 2. (wikipedia.org)
  • This article will focus on two such classes, synthetic cathinones and synthetic cannabinoids, and the emergence of such classes of drugs in the mainstream retail market, as well as the efficacy of legislation enacted to combat the use of these hazardous substances. (naag.org)
  • Therefore, synthetic drugs can combine the addictive properties of stimulants with the perception altering properties of hallucinogens. (naag.org)
  • Researchers have found that the use of these drugs can permanently alter brain chemistry, meaning that some of the side effects associated with the use of synthetic cathinones can be permanent. (naag.org)
  • These resources are now used to manufacture synthetic drugs for illegal use. (naag.org)
  • Synthetic drugs were initially manufactured in small clandestine laboratories and sold on the street, similar to narcotics such as cocaine and heroin. (naag.org)
  • These synthetic drugs are marketed towards young adults, with brand names like �Mr. Smiles� and �Moon Rocks. (naag.org)
  • In addition to the unpredictable side effects caused by synthetic drug use, there is little information regarding the long-term effects of these substances. (naag.org)
  • Synthetic urine is readily available for purchase online, with many of those companies specifically boasting of their ability to dupe drug tests. (sltrib.com)
  • Legislation backed by the administration of Mayor Stephanie Rawlings-Blake would empower city health inspectors to fine - and eventually shut down - retailers that sell synthetic drugs long criticized for appealing to youths with cartoon character marketing and claims of being natural and safe. (dailypress.com)
  • The city joins Baltimore County in beefing up its laws on synthetic drugs. (dailypress.com)
  • The county passed legislation last year that tightened a local ban on synthetic marijuana by broadening the definition of drugs that are banned. (dailypress.com)
  • We have the same goals with respect to trying to eliminate and reduce the sales of synthetic drugs in the city,' said Ellen Valentino with the Mid-Atlantic Petroleum Distributors Association. (dailypress.com)
  • Dr. Joshua Sharfstein, who was Maryland health secretary when statewide legislation banned the sale of synthetic drugs, said the city's initiative could give it more resources in curbing their sale. (dailypress.com)
  • Baker's legislation, which would raise $15 million to $20 million a year, could help the state pay for treatment centers and for an integrated prescription monitoring system to help doctors and pharmacists see if a patient has been doctor shopping to get more pills. (wctrib.com)
  • Amy Klobuchar (D-Minn.), John McCain (R-Ariz.) and Chuck Grassley (R-Iowa) called for the White House and HHS to certify the importation of medicines from Canada, allowing the FDA to permit pharmacists and wholesalers to purchase the drugs, as well as issue waivers to individuals for personal use. (fdanews.com)
  • AUSTIN, Texas - Legislation proposed in Texas' state legislature would expand the range of vaccines that pharmacists can administer to children. (drugstorenews.com)
  • Drug-induced homicide laws, on the other hand, discourage people from seeking emergency assistance for fear of prosecution for manslaughter or murder. (baltimoresun.com)
  • This article is Part I of a NAAGazette series that addresses the nation�s designer drug epidemic. (naag.org)
  • Unfortunately, our state is suffering from a major drug epidemic, and we want to be a part of whatever we can do to spread the message about scary drugs,' said Cailey Locklair Tolle, president of the Maryland Retailers Association. (dailypress.com)
  • Jacksonville Sheriff Mike Williams presented this award to Senator Bean in appreciation for supporting drug control legislation to address Florida's heroin and Fentanyl epidemic. (flsenate.gov)
  • Cathryn Donaldson, the group's director of communications and public affairs, said AHIP has not taken a stance on either of the Sanders' bills, but they support efforts to bring down drug prices. (healthline.com)
  • (TANF Drug Testing Legislation) "During 2010 and the first half of 2011, legislators in 31 states have proposed 82 bills that would require drug tests of TANF applicants and/or recipients. (drugwarfacts.org)
  • In addition, while nearly all bills focus on testing adult applicants or recipients, a small minority of State bills would require youth aged 13 or older be tested and proposed legislation in one State would require that all benefit recipients, including children under 12, be tested. (drugwarfacts.org)
  • Unlike bills that would only give consumers this ability to import drugs-something lots of people are doing anyway-this would turn the market upside-down by letting the big U.S. pharmacy companies and drug wholesalers do it. (blogspot.com)
  • This report discusses differences in the specifics of the prescription drug provisions in S. 1 and H.R. 1 and provides a side-by-side comparison of the Title I provisions of both bills. (unt.edu)
  • The UNCAC Legal Library is a comprehensive database of anti-corruption and asset recovery legislation and jurisprudence from over 175 States, systematized in accordance with the requirements of the Convention. (infodocket.com)
  • In related news, Emanuel and Sen. Jon Corzine (D-N.J.) on Tuesday spoke to 20 Johnson & Johnson executives, calling on the drug industry to address complaints about rising prescription drug prices. (californiahealthline.org)
  • 2 ) See EMA press release of 2.7.2012 at 'News and events' and Article 28c of the new legislation. (europa.eu)
  • New Legislation Makes Procedural Changes to DFEH Enforcement and. (natlawreview.com)
  • State and federal law prohibits the drugs, known by such names as K2 and Spice, but enforcement has proved difficult, mainly because manufacturers change the packaging and chemical makeup of the drugs to avoid prosecution. (dailypress.com)
  • The legislation introduced Monday would give the city an additional layer of civil enforcement power, and city officials hope it puts pressure on businesses to follow the law or risk losing their livelihood. (dailypress.com)
  • The trickiest part of this has been enforcement, and the legislation appears to bring all the tools the city has to bear on this challenge,' said Sharfstein, now an associate dean at the Johns Hopkins Bloomberg School of Public Health. (dailypress.com)
  • Earlier today, FDA announced that the Agency plans to take enforcement action with respect to marketed unapproved drugs containing hydrocodone. (fdalawblog.net)
  • The announced enforcement action is the first since May 2007 when FDA announced enforcement action on marketed unapproved timed-release guaifenesin drug products. (fdalawblog.net)
  • FDA does not expect to issue Warning Letters or any other further warnings to firms marketing unapproved hydrocodone drug products prior to taking enforcement action. (fdalawblog.net)
  • The Violent Crime Control and Law Enforcement Act of 1994 (PDF) extended ONDCP's mission to assessing budgets and resources related to the National Drug Control Strategy. (whitehousedrugpolicy.org)
  • March 24, 2015 - NIDA's Dr. Susan Weiss, along with representatives from the FDA, Drug Enforcement Administration and the Department of Justice, met with staff from Senator Kirsten Gillibrand (D-NY). (drugabuse.gov)
  • We reported in our 2015 Mid-Year FDA and Health Care Compliance and Enforcement Update on Drugs and Devices ("2015 Mid-Year Update") that the U.S. House of Representatives passed the 21st Century Cures Act, but the last six months saw little (if any) legislative progress. (gibsondunn.com)
  • DOJ enforcement actions in the drug and device industries have continued apace during the second half of 2015. (gibsondunn.com)
  • If, as the DOJ has pledged, the government ramps up its pursuit of individuals, the types of enforcement actions detailed below will become all the more complex from a legal (and strategic) perspective for drug and device companies. (gibsondunn.com)
  • After spending billions of dollars on law enforcement, doubling the number of arrests and incarcerations, and building prisons at a record pace, the system has failed to decrease the level of drug-related crime. (wikipedia.org)
  • Objective To quantify the potential effect of reciprocal approval legislation on access to clinically impactful therapeutics in the USA. (bmj.com)
  • The FDAAA extended the authority to levy fees to companies applying for approval of drugs, expanded clinical trial guidelines for pediatric drugs, and created the priority review voucher program. (govtrack.us)
  • In addition, Central America and the Caribbean are key transit regions for drugs entering the United States. (house.gov)
  • While billions of U.S. taxpayer dollars have been spent over the years to combat the drug trade in Latin America and the Caribbean, illegal drug use in the United States remains high. (house.gov)
  • More information about GDUFA II is available on the Generic Drug User Fee Amendments Implementation Activities page. (fda.gov)
  • In 2012, there were an estimated 23,900,000 illicit drug users in the United States. (house.gov)
  • Also, the reduction of illicit drug trafficking and production abroad. (wikipedia.org)
  • It will require drugmakers and drug importers to pay a percentage of the subsidized part of drugs which carry a fixed subsidy and a part of the subsidized part of drugs which carry a proportional subsidy. (bbj.hu)
  • The second would make it easier to import prescription drugs from Canada and other countries. (healthline.com)
  • American taxpayers make unique investment in drug research," he said. (healthline.com)
  • Public Citizen challenges Big Pharma, device manufacturers and federal regulators to make drugs and medical devices safe, effective and accessible to all. (citizen.org)
  • The legislation will make certain types of hearing aids available over-the-counter to Americans with mild to moderate hearing impairment. (drugstorenews.com)
  • Implementation of the legislation should make it much easier for the FDA to revise monographs to reflect the latest science and respond to safety issues and innovations. (pewtrusts.org)
  • The Western Hemisphere Drug Policy Commission Act of 2014 would create an independent commission to evaluate American drug policies and programs, assess which efforts are succeeding, and make recommendation on future counternarcotics policy. (house.gov)
  • Dave Baker, a member of the state House of Representatives, turned his pain into passion and plans to offer legislation that could make Minnesota the first in the nation to require drug companies to pay a surcharge of one cent on each opioid pill sold. (wctrib.com)
  • Dave Baker is planning to introduce legislation that could make Minnesota the first in the nation to require drug companies to pay a surcharge of one cent on each opioid pill sold. (wctrib.com)
  • Canadian Prime Minister Stephen Harper's government submitted legislation Monday that would make pipeline operators liable for costs and damages from spills totaling up to one billion Canadian dollars ($870 million), part of a package of changes designed to shore up public support for major pipeline projects. (wsj.com)
  • Title IV of the Improving Schools Act, called Safe and Drug-Free Schools and Communities, outlines legislation and initiatives to make schools safe. (encyclopedia.com)
  • Drug drive law is changing to make it easier for the police to detect and prosecute drug drivers. (bikewisenews.org.uk)
  • The Act amended 21 U.S.C. 844 to make crack cocaine the only drug with a mandatory minimum penalty for a first offense of simple possession. (wikipedia.org)
  • MANCHESTER, N.H. (AP) - Medical providers and first responders on Monday urged Sen. Kelly Ayotte to consider further incorporating mental health treatment into her efforts to address New Hampshire's heroin and prescription drug crisis. (washingtontimes.com)
  • Legislation to increase penalties for trafficking or making fentanyl could go before the Missouri House in Jefferson City on Monday afternoon for a final vote. (missourinet.com)
  • Ergo, in New Jersey chemical sample from an accused person should only be given on a voluntarily basis, and no penalties or sanctions apply for refusal to submit to chemical testing for drugs. (norml.org)
  • The penalties for drug driving are the same as for drink driving. (bikewisenews.org.uk)
  • The change from the Act of 1986 to the Act of 1988 concerns the mandatory minimum penalties to drug trafficking conspiracies and attempts that previously were applicable only to substantive completed drug trafficking offenses. (wikipedia.org)
  • High prescription drug prices have been attributed to government-granted monopolies to manufacturers and organizations lacking ability to negotiate prices. (wikipedia.org)
  • Drugs made in the U.S. are less expensive in Canada because the country has a single-payer program, so the government has the power to negotiate with drug companies for cheaper prices. (hightimes.com)
  • For any company looking to globalise their business, the governance of reporting adverse drug events by different centralised authorities, along with heterogeneous terminologies and competing priorities has created greater uncertainties and barriers to enter new markets. (smi-online.co.uk)
  • The governor and his administration, along with the General Assembly, should move away from the criminal justice system as the mechanism for addressing drug use and overdose, and should instead adopt evidence-based harm-reduction strategies to increase access to treatment and health services. (baltimoresun.com)
  • The health fund will have the right to sanction doctors who prescribe more expensive drugs containing the same active ingredient without any special reason. (bbj.hu)
  • The legislation has been endorsed by Cancer Prevention and Treatment Fund, Jacobs Institute for Women's Health, National Consumers League, National Research Center for Women & Families, Our Bodies Ourselves, and Union of Concerned Scientists. (drugs.com)
  • Hospital emergency rooms have seen an increase in the number of people showing up with health complications after using the drugs, city officials said, although they did not provide specific statistics. (dailypress.com)
  • Officials with Health Care for the Homeless said that over the summer, their doctors responded to two or three cases a day of people sickened after taking the drugs. (dailypress.com)
  • The legislation would limit a health plan's ability to require or encourage the use of any particular mail order pharmacy by placing restrictions on all health insurance policies and insurers that provide prescription drug coverage. (drugs.com)
  • For drugs whose authorization is based on prospective case series, most applications for reimbursement within public health care are granted. (arctichealth.org)
  • Generic biotech medications could save sponsors of US health plans, including employers and the federal government, $71 billion over 10 years, according to Express Scripts Inc., a manager of prescription drug benefits based in Maryland Heights, Missouri. (bbj.hu)
  • CCHR, joined by scores of parents and civil rights groups, say the New Freedom Commission on Mental Health's recommendations for mandatory mental health screening in school is a frightening representation of Aldous Huxley's Brave New World, in which Huxley describes a controlled "utopian" civilization achieved with the "technique of suggestion-through infant conditioning and, later, with the aid of drugs. (laleva.org)
  • Dr. Julian Whitaker, director of California's Whitaker Wellness Center warns that the motive behind mandatory mental health screening of children is obvious: "That means drugging them! (laleva.org)
  • That means that health plans and large, self-insured employer groups could directly benefit from a drug reimportation scheme. (blogspot.com)
  • FDA approves much-debated Alzheimer's drug panned by experts Government health officials on Monday approved the first new drug for Alzheimer's disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn't been shown to help slow the brain-destroying disease. (robertscottbell.com)
  • [1] The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the U.S. health care reform debate of 2009, and received renewed attention in 2015. (wikipedia.org)
  • [5] However, the government does employ drug pricing strategies for other smaller government health programs like the Veterans Health Administration , the Department of Defense , the 340B Drug Pricing Program (1992), and Medicaid . (wikipedia.org)
  • January 21, 2015 - NIDA staff attended a briefing sponsored by the Friends of National Institute of Child Health and Human Development: Opioid Use: Protecting the Most Vulnerable - Addressing Drug Exposure in Mothers and Newborns. (drugabuse.gov)
  • This is why Americans spend more than $310 billion a year on prescription drugs - drugs made by companies in which Tom Price, Donald Trump's health secretary, has bought stock. (hightimes.com)
  • Legislation under consideration by the 108th and earlier Congresses is intended to assist small employers in offering health insurance as a benefit to their workers. (unt.edu)
  • Many state legislatures have recognized that certain acts committed under these circumstances have potentially greater harmful effects to the health and safety of people and have implemented legislation accordingly. (encyclopedia.com)
  • What drug legislation do you need to know as an occupational health professional? (cansfordlabs.co.uk)
  • Understanding drug testing legislation and occupational health and safety protocol is a daunting task with all the different laws out there. (cansfordlabs.co.uk)
  • This guidance outlines factors to consider when creating drug products to reduce design -associated medication errors. (ahrq.gov)
  • Many local and federal legislation in the UK outlines this. (cansfordlabs.co.uk)
  • GDUFA enables FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications. (fda.gov)
  • These regulations are the Misuse of Drugs Amendment Regulations 2013. (legislation.govt.nz)
  • The Misuse of Drug Act was passed in 1971 largely to combat possession of illegal drugs and other substances. (cansfordlabs.co.uk)
  • Minister of Natural Resources Greg Rickford, who introduced the legislation to Canada's parliament, first announced the changes back in May. (wsj.com)