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Approved drugs
In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application.
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- Part of Speech: noun
- Synonym(s):
- Blossary:
- Industry/Domain: Pharmaceutical
- Category: Clinical trials
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