United States Food and Drug Administration: An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.Drug Approval: Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.World Health Organization: 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.Politics: Activities concerned with governmental policies, functions, etc.Stevens-Johnson Syndrome: Rare cutaneous eruption characterized by extensive KERATINOCYTE apoptosis resulting in skin detachment with mucosal involvement. It is often provoked by the use of drugs (e.g., antibiotics and anticonvulsants) or associated with PNEUMONIA, MYCOPLASMA. It is considered a continuum of Toxic Epidermal Necrolysis.United StatesHealth Care Reform: 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.Biological Science Disciplines: All of the divisions of the natural sciences dealing with the various aspects of the phenomena of life and vital processes. The concept includes anatomy and physiology, biochemistry and biophysics, and the biology of animals, plants, and microorganisms. It should be differentiated from BIOLOGY, one of its subdivisions, concerned specifically with the origin and life processes of living organisms.Science: The study of natural phenomena by observation, measurement, and experimentation.Food: Any substances taken in by the body that provide nourishment.Endpoint Determination: Establishment of the level of a quantifiable effect indicative of a biologic process. The evaluation is frequently to detect the degree of toxic or therapeutic effect.Glioblastoma: A malignant form of astrocytoma histologically characterized by pleomorphism of cells, nuclear atypia, microhemorrhage, and necrosis. They may arise in any region of the central nervous system, with a predilection for the cerebral hemispheres, basal ganglia, and commissural pathways. Clinical presentation most frequently occurs in the fifth or sixth decade of life with focal neurologic signs or seizures.SEER Program: A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)Product Surveillance, Postmarketing: Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.Antibodies, Monoclonal, Humanized: Antibodies from non-human species whose protein sequences have been modified to make them nearly identical with human antibodies. If the constant region and part of the variable region are replaced, they are called humanized. If only the constant region is modified they are called chimeric. INN names for humanized antibodies end in -zumab.Macau: Special Administrative Region of the People's Republic of China since December 20, 1999 with its own constitution. The island of Macau and adjacent islands are located off the southeast coast of China.Hong Kong: The former British crown colony located off the southeast coast of China, comprised of Hong Kong Island, Kowloon Peninsula, and New Territories. The three sites were ceded to the British by the Chinese respectively in 1841, 1860, and 1898. Hong Kong reverted to China in July 1997. The name represents the Cantonese pronunciation of the Chinese xianggang, fragrant port, from xiang, perfume and gang, port or harbor, with reference to its currents sweetened by fresh water from a river west of it.Encyclopedias as Topic: Works containing information articles on subjects in every field of knowledge, usually arranged in alphabetical order, or a similar work limited to a special field or subject. (From The ALA Glossary of Library and Information Science, 1983)Lions: Large, chiefly nocturnal mammals of the cat family FELIDAE, species Panthera leo. They are found in Africa and southern Asia.Acute Kidney Injury: Abrupt reduction in kidney function. Acute kidney injury encompasses the entire spectrum of the syndrome including acute kidney failure; ACUTE KIDNEY TUBULAR NECROSIS; and other less severe conditions.Animals, ZooChina: A country spanning from central Asia to the Pacific Ocean.ArchivesNigeria: A republic in western Africa, south of NIGER between BENIN and CAMEROON. Its capital is Abuja.Legislation, Drug: Laws concerned with manufacturing, dispensing, and marketing of drugs.Post-Exposure Prophylaxis: The prevention of infection or disease following exposure to a pathogen.Organophosphonates: Carbon-containing phosphonic acid compounds. Included under this heading are compounds that have carbon bound to either OXYGEN atom or the PHOSPHOROUS atom of the (P=O)O2 structure.Adenine: A purine base and a fundamental unit of ADENINE NUCLEOTIDES.Drug Industry: 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.Anti-HIV Agents: Agents used to treat AIDS and/or stop the spread of the HIV infection. These do not include drugs used to treat symptoms or opportunistic infections associated with AIDS.HIV Infections: Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).Rabies: Acute VIRAL CNS INFECTION affecting mammals, including humans. It is caused by RABIES VIRUS and usually spread by contamination with virus-laden saliva of bites inflicted by rabid animals. Important animal vectors include the dog, cat, bat, fox, raccoon, skunk, and wolf.Societies, Nursing: Societies whose membership is limited to nurses.Therapies, Investigational: Treatments which are undergoing clinical trials or for which there is insufficient evidence to determine their effects on health outcomes; coverage for such treatments is often denied by health insurers.Drugs, Generic: Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies.Equipment Safety: Freedom of equipment from actual or potential hazards.Device Approval: Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.Biosimilar Pharmaceuticals: BIOLOGIC PRODUCTS that are imitations but not exact replicas of innovator products.Helminthiasis, Animal: Infestation of animals with parasitic worms of the helminth class. The infestation may be experimental or veterinary.Liability, Legal: Accountability and responsibility to another, enforceable by civil or criminal sanctions.ArgentinaElectronic Mail: Messages between computer users via COMPUTER COMMUNICATION NETWORKS. This feature duplicates most of the features of paper mail, such as forwarding, multiple copies, and attachments of images and other file types, but with a speed advantage. The term also refers to an individual message sent in this way.Paratuberculosis: A chronic GASTROENTERITIS in RUMINANTS caused by MYCOBACTERIUM AVIUM SUBSPECIES PARATUBERCULOSIS.Mycobacterium avium subsp. paratuberculosis: A subspecies of gram-positive, aerobic bacteria. It is the etiologic agent of Johne's disease (PARATUBERCULOSIS), a chronic GASTROENTERITIS in RUMINANTS.Internet: A loose confederation of computer communication networks around the world. The networks that make up the Internet are connected through several backbone networks. The Internet grew out of the US Government ARPAnet project and was designed to facilitate information exchange.Periodicals as Topic: A publication issued at stated, more or less regular, intervals.Software: Sequential operating programs and data which instruct the functioning of a digital computer.Coitus Interruptus: A contraceptive method whereby coitus is purposely interrupted in order to prevent EJACULATION of SEMEN into the VAGINA.City Planning: Comprehensive planning for the physical development of the city.Nursing Administration Research: Research concerned with establishing costs of nursing care, examining the relationships between nursing services and quality patient care, and viewing problems of nursing service delivery within the broader context of policy analysis and delivery of health services (from a national study, presented at the 1985 Council on Graduate Education for Administration in Nursing (CGEAN) meeting).Economic Development: Mobilization of human, financial, capital, physical and or natural resources to generate goods and services.Research Support as Topic: Financial support of research activities.

U.S. Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis. (1/1514)

In August 1997, AmBisome (liposomal amphotericin B, Nexstar, San Dimas, CA) was the first drug approved for the treatment of visceral leishmaniasis by the U.S. Food and Drug Administration. The growing recognition of emerging and reemerging infections warrants that safe and effective agents to treat such infections be readily available in the United States. The following discussion of the data submitted in support of the New Drug Application for AmBisome for the treatment of visceral leishmaniasis shows the breadth of data from clinical trials that can be appropriate to support approval for drugs to treat tropical diseases.  (+info)

Advances in the biological therapy and gene therapy of malignant disease. (2/1514)

Biological and gene therapy of cancer have become important components of clinical cancer research. Advances in this area are based on evidence for the presence of tumor antigens, antitumor immune responses, evasion of host control by tumors, and the recognition of host defense failure in cancer patients. These mechanisms are being corrected or exploited in the development of biological and gene therapy. Over the last decade, 9 biological therapies have received Food and Drug Administration approval, and another 12 appear promising and will likely be approved in the next few years. Our approach to gene therapy has been to allogenize tumors by the direct intratumoral injection of HLA-B7/beta2-microglobulin genes as plasmid DNA in a cationic lipid into patients with malignant melanoma. In four Phase I studies, we found a 36% response by the local injected tumor and a 19% systemic antitumor response. In other cancers, gene transfer, expression, and an intratumoral T-cell response were seen, but no clinical response was seen. A variety of follow-up studies with HLA-B7 and other genes are planned. Evasion of host control is now a major target of gene therapy. Strategies to overcome this include up-regulation of MHC and introduction of cell adhesion molecules into tumor cells, suppression of transforming growth factor and interleukin 10 production by tumor cells, and blockade of the fas ligand-fas interaction between tumor cells and attacking lymphocytes. With these approaches, it seems likely that gene therapy may become the fifth major modality of cancer treatment in the next decade.  (+info)

The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: information for the investigator. (3/1514)

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)

Availability of immune globulin intravenous for treatment of immune deficient patients--United States, 1997-1998. (4/1514)

Immune globulin intravenous (IGIV) is a lifesaving treatment for patients with primary immunodeficiency. Since November 1997, a shortage of IGIV has existed in the United States. In 1998, the Food and Drug Administration (FDA) required pharmaceutical companies to increase the frequency of reporting on IGIV distribution from biannually to monthly; in addition, FDA facilitated IGIV distribution and informed clinicians about the ongoing shortage. To assess the impact of the IGIV shortage on patient care, in 1998 the Immune Deficiency Foundation (IDF) surveyed physicians caring for immunodeficient patients about whether they have had difficulty obtaining IGIV, measures they have taken because of the shortage, and the effect of the shortage on their patients. This report summarizes data reported to FDA and data obtained from the IDF survey and provides recommendations for IGIV use during the shortage.  (+info)

Procedure for expediting determinations of antibiotic susceptibility of gram-negative, urinary tract pathogens. (5/1514)

Standardized direct disk diffusion antibiotic susceptibility testing on monomicrobial urine specimens is compared with the Food and Drug Administration method. The direct procedure yields acceptable data and may conserve 24 h in reporting results.  (+info)

Herbal remedies: adverse effects and drug interactions. (6/1514)

A growing number of Americans are using herbal products for preventive and therapeutic purposes. The manufacturers of these products are not required to submit proof of safety and efficacy to the U.S. Food and Drug Administration before marketing. For this reason, the adverse effects and drug interactions associated with herbal remedies are largely unknown. Ginkgo biloba extract, advertised as improving cognitive functioning, has been reported to cause spontaneous bleeding, and it may interact with anticoagulants and antiplatelet agents. St. John's wort, promoted as a treatment for depression, may have monoamine oxidase-inhibiting effects or may cause increased levels of serotonin, dopamine and norepinephrine. Although St. John's wort probably does not interact with foods that contain tyramine, it should not be used with prescription antidepressants. Ephedrine-containing herbal products have been associated with adverse cardiovascular events, seizures and even death. Ginseng, widely used for its purported physical and mental effects, is generally well tolerated, but it has been implicated as a cause of decreased response to warfarin. Physicians must be alert for adverse effects and drug interactions associated with herbal remedies, and they should ask all patients about the use of these products.  (+info)

Modernizing the FDA: an incremental revolution. (7/1514)

The U.S. Food and Drug Administration (FDA) is responsible for protecting consumers from unsafe or ineffective drugs and medical devices. The agency's role is defined by a growing and increasingly complex set of statutes, which reflect Congress's desires, on the one hand, to prevent product hazards and, on the other, to expedite FDA review and approval of promising new medical technologies. Congress's latest attempt to calibrate regulation to achieve these goals, the 1997 Food and Drug Administration Modernization Act, endorses certain of the FDA's own innovations and changes in the agency's ways of doing business.  (+info)

When is a cost-effectiveness claim valid? How much should the FDA care? (8/1514)

Federal law requires the Food and Drug Administration (FDA) to regulate the promotional claims of prescription drugs and certain devices. Standards of evidence for claims of safety and therapeutic efficacy are rigorous because inappropriate product use may place human life at risk. However, equally demanding criteria for claims of cost-effectiveness of marketed technologies seem to be unnecessary because the consequence of error is principally a bad buy rather than patient harm. Concern exists about the validity of cost-effectiveness studies, the potential for bias, standards for the conduct of cost-effectiveness research, and the needs of managed care. The FDA should moderate its role in regulating cost-effectiveness claims of drugs and devices. This would foster information flow to healthcare providers and insurers and protect the FDA concern regarding false or misleading claims of effectiveness. Although the issues are applicable to both devices and drugs, we draw mainly from the field of pharmacoeconomics because this is where most of the policy has developed.  (+info)

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  • Principal investigator of the VISTOGARD clinical development program, Wen Wee Ma, MD, Associate Professor of Oncology, GI Cancers & Drug Development Program, Roswell Park Cancer Institute, commented: "Severe 5-FU toxicity has, historically, been difficult to treat and sometimes resulted in death for those affected. (btgplc.com)
  • Potentially life-threating or lethal toxicity from 5-FU can occur if the drug has been administered at a dose or rate greater than intended, or when a patient has genetic variations, impaired clearance or other factors that increase susceptibility to the toxicities of the drug. (btgplc.com)
  • It is important to recognize the signs of severe 5-FU and capecitabine toxicity early, which often include unexpected side effects on the first cycle - including gastrointestinal toxicities such as mucositis, central nervous system toxicities such as altered mental state, hematologic toxicities, and even cardiotoxicity. (btgplc.com)
  • Perhaps the only way to prevent conflicts of interest while ensuring the highest safety standards would be to rigorously test every drug or medical device, regardless of similarity to previous approved products and, furthermore, for the federal government to be the sole source of FDA funding. (yalescientific.org)
  • The United States Food and Drug Administration has given emergency authorisation for the use of plasma to treat coronavirus patients. (tvcnews.tv)
  • In combination with other drugs or radiation, 5-FU is a mainstay of chemotherapy across a variety of solid tumors, including those of the colon, pancreas, stomach, esophagus, breast, and head and neck. (btgplc.com)
  • For an agency that regulates over 25 percent of all consumer spending in the United States and is tasked with ensuring the safety of every person who purchases food or uses medicine, it is reasonable to allocate more than the eight dollars per American that Congress budgeted for the agency in 2012. (yalescientific.org)
  • However, the roughly $2 billion per year the FDA currently receives from drug companies as "user fees" raises the potential for conflicts of interest between sound science and financial motives. (yalescientific.org)
  • 5 U.S.C. § 801(a)(3)(A). The November 2015 rule had a stated effective date of January 26, 2016. (gao.gov)
  • Outbreaks of cholera in 2015-2016 include South Sudan, United Republic of Tanzania, and Kenya, with over 216 deaths and most recently, 121 people diagnosed with cholera in Iraq, their first outbreak since 2012 and in Cuba, the first outbreak in over 130 years. (medicinenet.com)
  • In releasing the agenda, the Administration highlights its 'ongoing progress toward the goals of more effective and less burdensome regulation,' including its plans to finalize three deregulatory actions for every new regulatory action in fiscal year 2018. (mondaq.com)
  • For instance, the Administration intends to issue a proposed regulation to 'remove unnecessary and outdated requirements from the conditions of participation for the Medicare and Medicaid programs for Long-Term Care facilities. (mondaq.com)
  • Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act. (jdsupra.com)
  • United States Food and Drug Administration Regulation of Gene and Cell Therapies. (cdc.gov)
  • Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. (wikipedia.org)
  • 1 E-cigarettes that are marketed without a therapeutic claim are not subject to regulation by the Food and Drug Administration (FDA). (aappublications.org)
  • GMOs are regulated in the United States under the Coordinated Framework for Regulation of Biotechnology, published in 1986, pursuant to previously existing statutory authority regulating conventional products, with a focus on the nature of the products rather than the process in which they are produced. (loc.gov)
  • 11 In Australia, the Therapeutic Goods Administration oversees the regulation of medical software products and devices, but does not regulate SCs because they are not classified as medical devices. (mja.com.au)
  • Worst of all, while consumers have a right to know what's in their food and how it's being produced, under current law, these genetically engineered salmon would not have to be labeled. (change.org)
  • The United States does not have any federal legislation that is specific to genetically modified organisms (GMOs). (loc.gov)
  • A series of polls conducted over five years, from 2001 to 2006, found that public understanding of biotechnology was relatively low, and that consumers were relatively unaware of the extent to which their foods included genetically modified ingredients. (loc.gov)
  • Support for the introduction of genetically modified foods into the food supply held steady at 26 to 27% of respondents in favor over that time period, while opposition to the introduction of such foods fell from 58 to 46% over the period. (loc.gov)
  • They will coordinate standards development as appropriate and assessment activities pertaining to the pre-market evaluation of veterinary drugs. (canada.ca)
  • Further work in this area will also explore the availability of electronic templates that could be used to submit veterinary drug applications. (canada.ca)
  • Since then, increasing numbers of Brachyspira isolations have been reported by veterinary diagnostic laboratories in the United States ( 9 ). (asm.org)
  • BARDA provides a systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. (medicalcountermeasures.gov)
  • FDA's responsibility is to ensure that medical countermeasures (MCMs)-such as drugs, vaccines, and diagnostic tests-to counter these threats are safe, effective, and secure. (medicalcountermeasures.gov)
  • This economic burden, increasing prevalence of Salmonella food-borne illness, and the ease by which disease-causing strains of Salmonella could be acquired and deliberately added to food supplies, have made Salmonella one of the microorganisms that is regarded as being a potential threat to national security. (faqs.org)
  • In this review article, we provide recent prevalence estimates for several cancer risk factors, including tobacco, obesity, physical activity, nutrition, ultraviolet radiation exposure as well as human papillomavirus and hepatitis B vaccination coverage and cancer screening prevalence in the United States. (aacrjournals.org)
  • This is unfortunate because 56% of new infections of HIV occur in the southern states, but less than 30% of PrEP users live there. (aidsmap.com)
  • According to FDA, it is establishing this rule because salmonella is one of the leading bacterial causes of food-borne illness in the United States and shell eggs are a primary source of human salmonella infections. (gao.gov)
  • As of January 2005, the CDC ArboNET has recorded avian or animal WNV infections in every state except Alaska , Hawaii , and Washington. (encyclopedia.com)
  • NEW DELHI: Drug firm Lupin Ltd has launched its generic Ciprofloxacin , used for treating bacterial infections, in the American market and is expecting 180 days of market exclusivity. (indiatimes.com)
  • It is still unknown how the WNV reached the continental United States , but it is suspected that the transport of infected birds or the international travel of infected humans may have been to blame. (encyclopedia.com)
  • In the spring and summer of 1996, an outbreak of cyclosporiasis in the United States and Canada was linked to eating raspberries imported from Guatemala (3). (cdc.gov)
  • After the outbreak in 1996, the berry industry in Guatemala, in consultation with the Food and Drug Administration (FDA) and CDC, voluntarily implemented a Hazard Analysis and Critical Control Point system and improved water quality and sanitary conditions on individual farms (3). (cdc.gov)
  • Variant Creutzfeldt-Jakob disease (vCJD) was first reported in 1996 in the United Kingdom and has been causally linked to eating cattle products contaminated with the bovine spongiform encephalopathy (BSE) agent ( 1 - 3 ). (cdc.gov)
  • Since April 1997, CDC has received reports of outbreaks of cyclosporiasis in the United States and Canada (1,2). (cdc.gov)
  • The guidance is intended to clarify the circumstances where the CDER (Center for Drug Evaluation and Research) may refuse to. (jdsupra.com)
  • Like Breana, he had struggled with drug dependence although appeared to be doing well: he had been through treatment for heroin dependence and worked at a rehabilitation center in Prescott, Arizona. (hrw.org)
  • Relatively minor changes in these viruses cause annual seasonal influenza outbreaks, which result in millions of illnesses, hundreds of thousands of hospitalizations, and tens of thousands of deaths each year in the United States. (whitehouse.gov)
  • The US federal and state governments are taking insufficient action to ensure access to the life-saving medication naloxone to reverse opioid overdose, resulting in thousands of preventable deaths. (hrw.org)
  • The was also a strong geographical difference in use: 329 women per 100,000 or one in 304 women took it in the north-east states (from New Jersey and Pennsylvania northwards) while only 140 per 100,000 (one in 714) took it in the southern states. (aidsmap.com)
  • In the United States, more than 100,000 patients annually may benefit from a reversal agent. (cnbc.com)
  • State of the art about influenza vaccination for advanced cancer patients receiving immune checkpoint inhibitors: When common sense is not enough. (cdc.gov)
  • Despite recommendations by the Centers for Disease Control and Prevention (CDC) that nearly every American should receive the influenza vaccine annually, however, seasonal influenza vaccination levels in the United States have currently reached only about 45 percent of CDC goals. (whitehouse.gov)
  • It is the policy of the United States to modernize the domestic influenza vaccine enterprise to be highly responsive, flexible, scalable, and more effective at preventing the spread of influenza viruses. (whitehouse.gov)
  • This is a public health and national security priority, as influenza has the potential to significantly harm the United States and our interests, including through large-scale illness and death, disruption to military operations, and damage to the economy. (whitehouse.gov)
  • This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related quality of life (QoL) of 300 civilian participants prior to and three months following state-of-the-art laser in situ keratomileusis (LASIK). (clinicaltrials.gov)
  • Cholera is most frequently transmitted by water sources contaminated with the causative bacterium Vibrio cholerae , although contaminated foods, especially raw shellfish, may also transmit the cholera-causing bacteria. (medicinenet.com)
  • Salmonella food poisoning results from the growth of the bacterium in food. (faqs.org)
  • Based on our additional review, the U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). (tunein.com)
  • The Trump administration has vowed to end the opioid epidemic, but has yet to address the issue of access to naloxone. (hrw.org)
  • 3 In the United States, two concentrations of liquid formulations of acetaminophen for infants are now available, further increasing the risk of incorrect dosing. (cmaj.ca)
  • Many people think of cannabis as a recreational drug, but, in recent years, many scientists have looked into how it might benefit people's health. (medicalnewstoday.com)
  • People know marijuana as a recreational drug, but it has played a medicinal role for thousands of years. (medicalnewstoday.com)
  • Under the RCC initiative, Health Canada and the U.S. Food and Drug Administration (FDA) are holding joint public consultation meetings on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines currently under development. (canada.ca)
  • MOUNTAIN VIEW, Calif. , June 8, 2011 /PRNewswire/ -- Edison Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has allowed an Expanded Access program to provide EPI-743 to seriously ill patients diagnosed with inherited respiratory chain diseases of the mitochondria. (prnewswire.com)
  • Health Canada and U.S. Food and Drug Administration will continue to work closely together to harmonize and align their pre and post-marketing surveillance requirements and standards (including pharmacovigilance issues) through the work of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and the International Pharmaceutical Regulators Forum. (canada.ca)
  • SOUTH SAN FRANCISCO, Calif., Dec. 18, 2015 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) announced today completion of the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational agent andexanet alfa, an FDA-designated breakthrough therapy specifically designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors. (cnbc.com)
  • A key challenge in realizing the potential clinical benefits of CO monitoring is that many monitors fail to track CO changes accurately when fluid and vasoactive drug therapy are administered," said Marc Zemel, S.M., M.B.A., co-founder and Chief Executive Officer of Retia Medical. (globenewswire.com)
  • Three hundred (300) participants planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism will be enrolled in this study from five (5) clinical sites across the United States. (clinicaltrials.gov)
  • Eating the food item that included raspberries was significantly associated with risk for illness for seven of the 15 events for which epidemiologic data are currently available (including for three of the events at which raspberries were not served with other types of berries) and was associated with illness but not significantly for six events (i.e., all or nearly all ill persons ate the berry item that was served). (cdc.gov)
  • While many of these can be innocuous in their normal intestinal environment, if they infect another area of the body (i.e., a cut) or contaminate food, illness can result. (faqs.org)
  • She remained in a state of akinetic mutism and died in June 2004, ≈32 months after illness onset. (cdc.gov)
  • 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)
  • Often a portion of the definition of a medical device is intended to differentiate between medical devices and drugs , as the regulatory requirements of the two are different. (wikipedia.org)
  • Consequences of infection reported among the identified cases included the need for frequent administration of antibiotic eye drops, multiple follow-up medical appointments, and permanent eye damage. (cdc.gov)
  • Health Canada and U.S. Food and Drug Administration will continue to work closely together on pre and post market regulatory convergence topics, including in particular, through the International Medical Devices Regulators Forum (IMDRF). (canada.ca)

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