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  5. Kathleen Uhl, M.D., Director, Office of Generic Drugs
  1. Center for Drug Evaluation and Research (CDER)

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Kathleen Uhl, M.D.Kathleen (Cook) Uhl, M.D. serves as the Director for the Office of Generic Drugs 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. 

Dr. Uhl began her career with FDA in 1998 as a medical officer in the Office of Clinical Pharmacology and has served in numerous positions at FDA, including five years as the Assistant Commissioner for Women’s Health and the Director of FDA’s Office of Women’s Health, and most recently as the Deputy Director of CDER’s Office of Medical Policy.

She received her undergraduate degree from Temple University and her medical degree from the Medical College of Pennsylvania, with subsequent fellowship training in medical research and clinical pharmacology at the Uniformed Services University. She serves on the Editorial Board for Clinical Pharmacology and Therapeutics. She retains faculty appointments as Professor in Family Medicine and Internal Medicine at the Uniformed Services University and is a retired officer of the U.S. Public Health Service Commissioned Corps.

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