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U.S. Department of Health and Human Services

Drugs

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Applied Regulatory Science

Applied regulatory scientists in the Center for Drug Evaluation and Research (CDER) represent a wide range of scientific disciplines and are focused on expanding CDER’s laboratory and computational research capabilities to close the gap between regulatory science and drug review.

Staff members conduct benchmark laboratory and computational research to inform FDA policy, relieve critical rate-limiting steps in the drug development process, and improve the evaluation, monitoring and prediction of drug safety and efficacy. These scientists also provide expert advice to CDER review divisions on preclinical and clinical aspects of pharmacology, toxicology, and drug exposure.