HIV/AIDS Glossary

Approved Drug

A drug approved by the Food and Drug Administration (FDA) for sale in the United States. The extensive FDA drug approval process includes many steps, including preclinical laboratory and animal studies, safety and efficacy clinical trials in humans, filing of a New Drug Application by the drug manufacturer, FDA review of the application, and FDA approval or rejection of the application.

Related Term(s): Clinical Trial, Food and Drug Administration, New Drug Application


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The phases of a clinical trial

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