Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including...
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Director, Office of Pharmaceutical Quality Operations, ORA, OGROP, FDA, United States
Director, Office of Pharmaceutical Quality Operations within FDA’s Office of Regulatory Affairs (ORA), responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic, working in conjunction with FDA Centers: CDER and CVM. Alonza is also leading...
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Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA
Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants...
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Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA, United States
Dr. Susan Rosencrance presently heads FDA's Office of Lifecycle Drug Products within the Office of Pharmaceutical Quality (OPQ). She provides executive leadership by overseeing and directing scientific review programs and activities related to evaluating drug product quality throughout...
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Director, FDA Office of Generic Drug Policy, FDA
Maryll W. Toufanian, J.D., serves as Acting Director of FDA’s Office of Generic Drug Policy (OGDP), which provides oversight and direction in the development of policies concerning all aspects of generic drugs, and advises the generic drug program on application-specific policy...
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Director, Office of Generic Drugs, CDER, FDA
Kathleen Uhl, MD currently serves as the Director for the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). This office is responsible for the review and approval of Abbreviated New Drug Applications (ANDAs) and...
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