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 |
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Prescription drugs Over-the-counter drugs |
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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 |
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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 |
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Non-governmental organizations |
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).
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See also
- Health care in the United States
- American Society of Consultant Pharmacists
- Boston Collaborative Drug Surveillance Program
- National Drug & Safety League
References
External links
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