Food and Drug Administration - Regulatory Programs

Regulatory Programs

Regulation of therapeutic goods in the United States
Prescription drugs
Over-the-counter drugs
Law Federal Food, Drug, and Cosmetic Act
Comprehensive Drug Abuse Prevention and Control Act of 1970
Controlled Substances Act
Prescription Drug Marketing Act
Drug Price Competition and Patent Term Restoration Act
Hatch-Waxman exemption
Government agencies Department of Health and Human Services
-Food and Drug Administration-
Department of Justice
-Drug Enforcement Administration-
Process Drug discovery
Drug design
Drug development
New drug application
Investigational new drug
Clinical trial (Phase I, II, III, IV)
Randomized controlled trial
Pharmacovigilance
Abbreviated New Drug Application
Fast track approval
Off-label use
International coordination International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use
Uppsala Monitoring Centre
World Health Organization
Council for International Organizations of Medical Sciences
Single Convention on Narcotic Drugs
Non-governmental organizations Institute of Medicine
Research on Adverse Drug events And Reports

The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety, yet FDA regulation of cosmetics is focused primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483.

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