Regulation of therapeutic goods in the United States

Regulation of therapeutic goods in the United States is carried out by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter at retail outlets and others by prescription only.

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
Marihuana Tax Act
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
NORML

The possession of some substances is prohibited by scheduling under the Controlled Substances Act, under the joint jurisdiction of the FDA and the Drug Enforcement Administration (DEA)

Pharmacovigilance

Three primary branches of pharmacovigilance in the U.S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as RADAR and Public Citizen).

See also

References
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