Food and Drug Administration
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The U.S. Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.
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See also
- Drug Efficacy Study Implementation
- Food and Drug Administration Modernization Act 1997
- FDA Food Safety Modernization Act 2011
- FDA Fast Track Development Program (for drugs)
- Food and Drug Administration Amendments Act of 2007 (e.g. drugs)
- Food and Drug Administration Safety and Innovation Act 2012 (GAIN/QIDP etc.)
- Inverse benefit law
- Investigational Device Exemption (for use in clinical trials)
- Kefauver Harris Amendment 1962 – required "proof-of-efficacy" for drugs
General:
International:
- Food Administration
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Brazil: National Health Surveillance Agency
- Canada: Marketed Health Products Directorate
- Canada: Health Canada
- Denmark: Danish Medicines Agency
- European Union: European Medicines Agency
- Germany: Federal Institute for Drugs and Medical Devices
- India: Food Safety and Standards Authority of India
- India: Central Drugs Standard Control Organization
- Japan: Ministry of Health, Labour and Welfare (MHLW)
- Japan: Pharmaceuticals and Medical Devices Agency
- Mexico: Federal Commission for the Protection against Sanitary Risk
- United Kingdom: Medicines and Healthcare Products Regulatory Agency
- United States: Food and Drug Administration
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