FDA regulates clinical investigations of regulated products under 21 CFR Parts 50, 54, 56, 312, and 812, among others. FDA inspects IRBs, sponsors, and clinical sites and can issue warning letters, clinical holds, or disqualifications when problems are found.
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Glossary Term
FDA (Food and Drug Administration)
Governance
Also known as: Food and Drug Administration, U.S. FDA
The U.S. agency that regulates drugs, biologics, and medical devices, including clinical investigations of these products.
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