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Regulation of therapeutic goods in the United States
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From Wikipedia, the free encyclopedia
Regulation of therapeutic goods in the United States
Prescription drugs
Over-the-counter drugs
Law
Federal Food, Drug, and Cosmetic Act
CDAPCA
Controlled Substances Act
Prescription Drug Marketing Act
Hatch-Waxman Act
exemptions
Marihuana Tax Act of 1937
Government agencies
Department of Health and Human Services
Food and Drug Administration
Department of Justice
DEA
Process
Drug discovery
Drug design
Drug development
New Drug Application
Investigational New Drug
Clinical trial
phases
Randomized controlled trial
Pharmacovigilance
Abbreviated New Drug Application
Fast track approval
Off-label use
International coordination
ICH
Uppsala Monitoring Centre
WHO
CIOMS
Single Convention on Narcotic Drugs
Non-governmental organizations
National Academy of Medicine
RADAR
NORML
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