ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Food and Drug Administration (FDA)

The U.S. Regulatory agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services, which, among other responsibilities, evaluates pharmaceutical candidates for safety and efficacy, and determines whether to authorize them to be marketed in the United States. Other countries have similar regulatory agencies that must grant marketing authorization before a drug can be sold there.

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