Template:Regulation of therapeutic goods in the United States Information & Template:Regulation of therapeutic goods in the United States Links at HealthHaven.com

Template:Regulation of therapeutic goods in the United States Information & Template:Regulation of therapeutic goods in the United States Links at HealthHaven.com

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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
United States Department of Health and Human Services Food and Drug Administration Drug Enforcement Administration Center for Drug Evaluation and Research

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

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