FDA Fast Track Development Program

U.S. drug regulation

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 National Institutes of Health Center for Drug Evaluation and Research

Process
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

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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The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration that accelerates the approval of investigational new drugs undergoing clinical trials. Such status is often given to agents that show promise in treating serious, life-threatening medical conditions for which no other drug either exists or works as well.

References

FDA website

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FDA Fast Track Development Program

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