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.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.United StatesClinical Trials as Topic: Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.Treatment Outcome: Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.Food: Any substances taken in by the body that provide nourishment.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.Food Labeling: 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.Administration, Oral: The giving of drugs, chemicals, or other substances by mouth.Food Supply: The production and movement of food items from point of origin to use or consumption.Equipment Safety: Freedom of equipment from actual or potential hazards.Food Analysis: Measurement and evaluation of the components of substances to be taken as FOOD.Drug Labeling: Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information.Food Preferences: The selection of one food over another.Drug Administration Schedule: Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.Elephantiasis, Filarial: Parasitic infestation of the human lymphatic system by WUCHERERIA BANCROFTI or BRUGIA MALAYI. It is also called lymphatic filariasis.Legislation, Food: Laws and regulations concerned with industrial processing and marketing of foods.

*  Federal Register :: Guidance for Industry, Designing Clinical Programs for Developing Human Drugs, Medical...

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Draft Guidance ... The Daily Journal of the United States Government. Legal Status. Legal Status. ...
https://federalregister.gov/documents/1996/03/06/96-5211/guidance-for-industry-designing-clinical-programs-for-developing-human-drugs-medical-devices-or

*  FDA Offers Draft Guidance on Organ Preservation Device Animal Studies | RAPS

... the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help industry with recommendations on best ... The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the ... There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in ... and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and ...
raps.org/Regulatory-Focus/News/2017/09/15/28482/FDA-Offers-Draft-Guidance-on-Organ-Preservation-Device-Animal-Studies/

*  Lutein, zeaxanthin and meso-zeaxanthin for eye health - Nutrition Express Articles

... advertising or product information have been evaluated or approved by the United States Food and Drug Administration (FDA). The ... Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to ... WARNING: These products contain chemicals known to the State of California to cause birth defects or other reproductive harm. ... California Consumers - Proposition 65 requires sellers to notify California consumers of substances that are in many foods, ...
https://nutritionexpress.com/article index/authors/newsletter editor/july 2013/showarticle.aspx?id=1897

*  Federal Register :: Draft Guidance for Industry on Submission of Documentation in Drug Applications for Container...

Submission of Documentation in Drug Applications for Container Closure Systems Used for the Packaging of Human Drugs and ... The Food and Drug Administration (FDA) is extending to November 14, 1997, the comment period on the agency's draft guidance for ... Food and Drug Administration Dates:. Written comments by November 14, 1997. General comments on agency guidance documents are ... A Notice by the Food and Drug Administration on 09/05/1997. ... The Daily Journal of the United States Government. Legal Status ...
https://federalregister.gov/documents/1997/09/05/97-23586/draft-guidance-for-industry-on-submission-of-documentation-in-drug-applications-for-container

*  Health Notes - Health Notes

... advertising or product information have been evaluated or approved by the United States Food and Drug Administration (FDA). The ... Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to ... WARNING: These products contain chemicals known to the State of California to cause birth defects or other reproductive harm. ... Nutrition facts are calculated by a food expert using nutritional values provided by the USDA for common products used as ...
https://nutritionexpress.com/hn/recipe/grilled-rack-of-asparagus/

*  Health Notes - Health Notes

... advertising or product information have been evaluated or approved by the United States Food and Drug Administration (FDA). The ... Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to ... The third phase is a weight-maintenance diet that primarily restricts only high-glycemic-index foods or foods high in saturated ... The diet emphasizes carbohydrate foods with a low glycemic index and fats that don't raise blood cholesterol. The South Beach ...
https://nutritionexpress.com/hn/diet/south-beach-diet/the-basics

*  Health Notes - Health Notes

... advertising or product information have been evaluated or approved by the United States Food and Drug Administration (FDA). The ... Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to ... WARNING: These products contain chemicals known to the State of California to cause birth defects or other reproductive harm. ... California Consumers - Proposition 65 requires sellers to notify California consumers of substances that are in many foods, ...
https://nutritionexpress.com/hn/health-condition/celiac-disease/quality-of-life

*  European Medicines Agency - News and Events - European Medicines Agency and United States Food and Drug Administration to share...

The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share ... European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections. * Email ... European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections. ... Working with the United States of America. *European Medicines Agency and its international partners complete successful ...
ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/12/news_detail_001399.jsp&mid=WC0b01ac058004d5c1&jsenabled=true

*  FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding

On May 18, 2015, the U.S. Food and Drug Administration ("FDA") withdrew its 2003 Compliance Policy Guide - Section 608.400, ... See United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fl. 2011) (holding that the FDCA did not authorize the FDA ... The Draft Guidance states that, like human drug compounding, the FDA aims to ensure that state-regulated traditional ... an approved human drug may be used for "extralabel use" under Sections 512(a)(4) and (5) of the Federal Food, Drug, and ...
ebglaw.com/news/fda-signals-restrictive-regulatory-approach-in-draft-guidance-on-animal-drug-compounding/

*  Health Notes - Health Notes

... advertising or product information have been evaluated or approved by the United States Food and Drug Administration (FDA). The ... Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to ... People in the southwestern United States and northern Mexico have long used chaparral tea to help calm upset stomachs. ... Stay away from foods that fuel the flames of heartburn and indigestion. According to research or other evidence, the following ...
https://nutritionexpress.com/hn/health-condition/indigestion-heartburn-and-low-stomach-acidity/helpful-supplements

*  BSE Info - United States Food and Drug Administration's Announcement of New Feed Regulations (1/26/2004)

United States Food and Drug Administration's Announcement of New Feed Regulations. Terry Stokes, Chief Executive Officer, ... The Food and Drug Administration (FDA) announced today several new measures designed to further strengthen the animal feed rule ...
bseinfo.org/unitedstatesfoodanddrugadministrationsannouncementofnewfeedregulations1262004.aspx

*  Federal Register :: Draft Guidance for Industry on Stability Testing of Drug Substances and Drug Products;...

Stability Testing of Drug Substances and Drug Products.'' The draft guidance provides recommendations regarding the stability ... The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled `` ... studies that should be performed to support new drug... ... Food and Drug Administration Dates:. Written comments on the ... A Notice by the Food and Drug Administration on 06/08/1998. ... The Daily Journal of the United States Government. Legal Status ...
https://federalregister.gov/documents/1998/06/08/98-15148/draft-guidance-for-industry-on-stability-testing-of-drug-substances-and-drug-products-availability

*  Phosphatidylserine (PS) holds great promise for brain health - Nutrition Express Articles

... advertising or product information have been evaluated or approved by the United States Food and Drug Administration (FDA). The ... Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to ... In February 2003, the Food and Drug Administration (FDA) announced that it would allow the following claims to accompany ... It's richly concentrated in the fat-soluble fraction of the same two food sources: eggs and soybeans. It's likely that more and ...
https://nutritionexpress.com/showarticle.aspx?articleid=265

*  European Medicines Agency - News and Events - European Medicines Agency and United States Food and Drug Administration seek...

11/08/2010 - The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) ... European Medicines Agency and United States Food and Drug Administration seek potential candidate companies for joint good- ... European Medicines Agency and United States Food and Drug Administration seek potential candidate companies for joint good- ... European Medicines Agency / Food and Drug Administration joint good-manufacturing-practice-inspection pilot programme - Terms ...
ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/08/news_detail_001102.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

*  Digestive enzymes: Help food absorption - Nutrition Express Articles

... advertising or product information have been evaluated or approved by the United States Food and Drug Administration (FDA). The ... Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to ... Supplemental enzymes can help restore enzyme levels to their youthful state. They can be used to improve the digestion of food ... As a result, you may not get all the good nutrition you expect to get from your food. Partially undigested food can pass ...
https://nutritionexpress.com/article index/brands/lindberg/showarticle.aspx?id=128

*  Government Documents E-Library: Food Code: Recommendations of the United States Public Health Service, Food and Drug...

Food Code: Recommendations of the United States Public Health Service, Food and Drug Administration. ... Local, state and federal regulators use the FDA Food Code as a model to help develop or update their own food safety rules and ... Also, many of the over one million retail food establishments apply Food Code provisions to their own operations. ... to be consistent with national food regulatory policy. ...
virtualref.com/govdocs/391.htm

*  The Food and Drug Administration's critical mission and challenges for the ... - United States. Congress. House. Committee on...

Drugs - United States - Testing. Food adulteration and inspection. Food adulteration and inspection - United States. Medical / ... The Food and Drug Administration's critical mission and ..., Volumes 74-77. United States. Congress. House. Committee on ... Drug_Administration_s_criti.html?id=emjpOfD1a-YC&utm_source=gb-gplus-shareThe Food and Drug Administration's critical mission ... Administration drug safety system drugs and biologies e-coli effective ensure Eschenbach FDA's Federal focus Food and Drug food ...
https://books.google.com/books?id=emjpOfD1a-YC&q=adverse events&dq=related:LCCN2006470499&source=gbs_similarbooks_r&hl=en

*  Category:Food and Drug Administration (United States) - Wikimedia Commons

Media in category "Food and Drug Administration (United States)". The following 200 files are in this category, out of 309 ... Food and Drug Administration (United States) (logo).jpg 609 × 480; 31 KB. ... Retrieved from "https://commons.wikimedia.org/w/index.php?title=Category:Food_and_Drug_Administration_(United_States)&oldid= ... Food and Drug Administration Center for Biologics Evaluation and Research‎ (1 C) ...
https://commons.m.wikimedia.org/wiki/Category:Food_and_Drug_Administration_

*  Inibidor da araquidonato 5-lipoxigenase - Wikipedia

doi:10.1093/abbs/gmt064 «Zyflo (Zileuton tablets)» (PDF). United States Food and Drug Administration. Cornerstone Therapeutics ...
https://pt.wikipedia.org/wiki/Inibidor_da_araquidonato_5-lipoxigenase

*  Pirrolizidínico - Wikipedia

United States Food and Drug Administration. Consultado em 10 de setembro de 2009 Fu, P.P., Yang, Y.C., Xia, Q., Chou, M.C., Cui ... Journal of Food and Drug Analysis, Vol. 10, No. 4, 2002, pp. 198-211 [2], em inglês Wiedenfeld H, Andrade-Cetto A., " ...
https://pt.wikipedia.org/wiki/Pirrolizidínico

*  PostLive - The Washington Post

Commissioner, United States Food and Drug Administration Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and ... Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration, goes in-depth about steps the U.S. government is taking ... In an interview with The Washington Post on Monday, U.S. Food and Drug Administration Commissioner Scott Gottlieb said the ... Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration, discusses the progress made in gene therapy for fighting ...
https://washingtonpost.com/post-live-2017-chasing-cancer/?utm_term=.afb20cb3be70

*  Animal Testing timeline | Timetoast timelines

... the United States Food and Drug Administration (FDA) passed the Federal Food, Drug and Cosmetic Act in 1938. ... becomes the first neurophysiologist in the United States to experiment on live animals as a part of classroom instruction. ... timetoast Physiologist Edmund O'Meara says, "the miserable torture of vivisection places the body in an unnatural state." He ... United States Food and Drug Administration (FDA) Animal Testing Timeline After an incident where a woman's personal use of a ...
timetoast.com/timelines/animal-testing--2

*  Carboplatin - Reports of Side Effects

... from United States on 2012-08-27 Patient: Reactions: Off Label Use, Gastrointestinal Toxicity, Neutropenia, Infection Drug(s) ... Administration route: Oral Start date: 2011-03-16 Prednisolone Dosage: 2 mg/m2, 1x/day Administration route: Oral Start date: ... Other drugs received by patient: Lorazepam; Warfarin Sodium; Nifedipine; Citalopram Hydrobromide; Fiornal; Joint Food; Tylox; ... Reported by a physician from United States on 2012-08-27 Patient: 68 year old male, weighing 74.5 kg (163.9 pounds) Reactions: ...
druglib.com/reported-side-effects/carboplatin/

*  The Sandman is from Mars: Defeating the Non-24hr sleep-wake syndrome

And in general stores across the United States, they sell blue-free bulbs to keep bugs away. Here's what I would like to say in ... Rule 11: Eating a healthy balanced diet (natural foods).. I eat a balanced and healthy diet. I do not eat any junk food or ... Melatonin administration can entrain the free-running circadian system of blind subjects. Journal of Endocrinology, Vol 164, ... Ignorance about sleep hygiene and relaxation methods is widespread, and I suspect drug companies are delighted with the status ...
non24.blogspot.com/2009/09/synopsis-from-my-teenage-years-until-my.html?showComment=1338187026091

*  PPT - Micronutrients Vitamins and Minerals PowerPoint Presentation - ID:4023338

These diseases are not a problem in the United States, but occasionally they occur when people omit certain foods or overeat ... Administration of high-potency doses in the range of 15,000 to 60,000 micrograms (μg) are distributed to young children in ... Drug activity, vitamins D2 (or ergocalciferol) and D3 (or cholecalciferol) are the two most significant to humans.Interactions ... While many common foods contain vitamin C, the best food sources are citrus fruits. One orange, a kiwi fruit, cup of grapefruit ...
slideserve.com/lonato/micronutrients-vitamins-and-minerals

IontocaineMarketing authorization: Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), finalized by granting of a document also called marketing authorization (MA) (equivalent: product license).Surrogate endpoint: In clinical trials, a surrogate endpoint (or marker) is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship. The National Institutes of Health (USA) defines surrogate endnpoint as "a biomarker intended to substitute for a clinical endpoint".List of Parliamentary constituencies in Kent: The ceremonial county of Kent,Community-based clinical trial: Community-based clinical trials are clinical trials conducted directly through doctors and clinics rather than academic research facilities. They are designed to be administered through primary care physicians, community health centers and local outpatient facilities.Banquet Foods: Banquet Foods is a subsidiary of ConAgra Foods that sells various food products, including frozen pre-made entrées, meals, and desserts.Food and Drug Administration Modernization Act of 1997Health claims on food labels: Health claims on food labels are claims by manufacturers of food products that their food will reduce the risk of developing a disease or condition. For example, it is claimed by the manufacturers of oat cereals that oat bran can reduce cholesterol, which will lower the chances of developing serious heart conditions.Osmotic controlled-release oral delivery system: OROS (Osmotic [Controlled] Release Oral [Delivery] System) is a controlled release oral drug delivery system in the form of a tablet. The tablet has a rigid water-permeable jacket with one or more laser drilled small holes.Food desert: A food desert is a geographic area where affordable and nutritious food is difficult to obtain, particularly for those without access to an automobile.USDA Defines Food Deserts | American Nutrition Association Some research links food deserts to diet-related health problems and health disparities in affected populations, but this phenomenon has been disputed.Medical device: A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).Summarised from the FDA's definition.Public Health Security and Bioterrorism Preparedness Response Act

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

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)

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

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)

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

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)

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

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)

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

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)

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

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)

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

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)

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

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)



America


  • The initiative will apply to inspections of manufacturing sites of human or veterinary medicines in the European Economic Area or United States of America. (europa.eu)
  • 11/08/2010 - The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. (europa.eu)

inspections


  • The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories. (europa.eu)

Federal Food


  • Animal Testing Timeline After an incident where a woman's personal use of a mascara darkener went awry, leaving her with burning eyes and ultimately - blindness - the United States Food and Drug Administration (FDA) passed the Federal Food, Drug and Cosmetic Act in 1938. (timetoast.com)

safety


  • Local, state and federal regulators use the FDA Food Code as a model to help develop or update their own food safety rules and to be consistent with national food regulatory policy. (virtualref.com)
  • The Spanish Food Safety and Nutrition Agency (AESAN) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding AESAN-regulated products as part of cooperative law enforcement or cooperative regulatory activities. (fda.gov)