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  1. Center for Drug Evaluation and Research | CDER

Sally Choe Ph.D.
Leadership Role
Director - Office of Generic Drugs

Sally Choe, Ph.D.
Sally Choe Ph.D.

Sally Choe, Ph.D., serves as Director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research. This office is responsible for the review and approval of Abbreviated New Drug Applications (ANDAs). Its mission is to ensure, through a scientific and regulatory process, that generic drugs are safe and effective for the American public.

From 2006 to 2011, Dr. Choe was leader of the metabolism and endocrinology team in CDER’s Office of Clinical Pharmacology, Office of Translational Sciences (OTS). Between 2011 and 2016, she served as senior director at PAREXEL International Corporation, overseeing the Asia-Pacific region and Japan offices, as well as managing the global Vice President Technical consultant group. Dr. Choe returned to FDA in January 2017 and served as deputy director of the Office of Study Integrity and Surveillance in OTS. With more than 20 years of experience in global drug development, Sally is a recognized expert in drug review, clinical pharmacology, biopharmaceutics, and pharmacokinetics.

She received her undergraduate degree in electrical engineering from Virginia Polytechnic and State University and her master’s and doctoral degrees in pharmaceutics from the University of Michigan.

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