Food and Drug Administration (United States) | Wikipedia audio article

This is an audio version of the Wikipedia Article:
Food and Drug Administration (United States)

00:01:57 1 Organizational chart
00:02:07 2 Location
00:03:00 3 Regional facilities
00:05:53 4 Scope and funding
00:08:14 5 Regulatory programs
00:09:46 5.1 Canada-United States Regulatory Cooperation Council
00:10:43 5.2 Food and dietary supplements
00:11:51 5.2.1 “FDA-Approved” vs. “FDA-Accepted in Food Processing”
00:12:40 5.3 Medications
00:13:18 5.3.1 New medications
00:14:58 Advertising and promotion
00:15:51 Postmarket safety surveillance
00:17:25 5.3.2 Generic drugs
00:18:14 Generic drug scandal
00:20:36 5.3.3 Over-the-counter drugs
00:21:13 5.3.4 Ebola treatment
00:21:46 5.4 Vaccines, blood and tissue products, and biotechnology
00:22:56 5.5 Medical and radiation-emitting devices
00:24:07 5.5.1 “FDA-Cleared” vs “FDA-Approved”
00:24:47 5.6 Cosmetics
00:26:14 5.7 Veterinary products
00:26:56 5.8 Tobacco products
00:28:49 5.9 Regulation of living organisms
00:29:40 6 Science and research programs
00:30:17 7 Data management
00:30:38 8 History
00:37:39 8.1 Historical first: FDA and Endo Pharmaceutical’s Opana ER (2017)
00:38:05 9 21st century reforms
00:38:15 9.1 Critical Path Initiative
00:38:47 9.2 Patients’ rights to access unapproved drugs
00:40:14 9.3 Post-marketing drug safety monitoring
00:42:50 9.4 Pediatric drug testing
00:45:31 9.5 Priority review voucher (PRV)
00:46:28 9.6 Rules for generic biologics
00:47:44 9.7 Mobile medical applications
00:48:16 10 Criticisms
00:51:04 11 See also

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The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget (approximately $700 million) is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act.The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Scott Gottlieb, M.D. is the current commissioner, who took over in May 2017.The FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.


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