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U.S. Department of Health and Human Services

Drugs

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Clinical Pharmacology

The mission of clinical pharmacologists in the Center for Drug Evaluation and Research (CDER) is to ensure the safety and effectiveness of new drugs through the evaluation of clinical pharmacology and biopharmaceutics data in support of CDER's Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) review programs.  

Clinical pharmacology staff members perform research to expand the FDA’s knowledge of clinical pharmacology in order to better evaluate benefit and risk, and to ensure that regulatory policy and decision making are based on the best available science.