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  5. Office of Generic Drugs | Offices and Divisions
  1. Center for Drug Evaluation and Research | CDER

Office of Generic Drugs | Offices and Divisions

Immediate Office

Phone: 240-402-7920 Fax: 301-595-1147

Sally Choe, Ph.D., Director, Office of Generic Drugs (OGD)

Janet McGinn, D.V.M., Deputy Director of Operations, which includes the Program Management Analysis Staff and various Immediate Office positions

Iilun C. Murphy, M.D., Deputy Director of Clinical and Regulatory Affairs, which includes the Communications Staff and various Immediate Office positions

William Chong, M.D., Associate Director of Clinical Affairs

Sarah Ibrahim, Ph.D., Associate Director of Global Generic Drug Affairs

Tawni Schwemer, Senior Advisor to the OGD Office Director

Samir Shaikh, M.B.A., Associate Director of Knowledge Management

Office of Bioequivalence (OB)

Partha Roy, Ph.D., Director, Office of Bioequivalence, which includes the three Divisions of Bioequivalence and a Division of Bioequivalence Process Management

Vacant, Deputy Director, Office of Bioequivalence

Office of Generic Drug Policy (OGDP)

Maryll W. Toufanian, J.D., Director, Office of Generic Drug Policy, which includes the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development

Kristin Davis, J.D., Deputy Director

Office of Research and Standards (ORS)

Rob Lionberger, Ph.D., Director, Office of Research and Standards, which includes the two Divisions of Therapeutic Performance and the Division of Quantitative Methods and Modeling

Lei Zhang, Ph.D., Deputy Director

Office of Regulatory Operations (ORO)

Edward “Ted” Sherwood, Director, Office of Regulatory Operations, which includes the Division of Filing Review, the Division of Labeling Review, and the Division of Project Management

LCDR Malik Imam, Pharm.D., Deputy Director

Office of Safety and Clinical Evaluation (OSCE)

Iilun C. Murphy, M.D., Acting Director, Office of Safety and Clinical Evaluation, which includes the Division of Clinical Review, Division of Pharmacology Toxicology Review, and Division of Clinical Safety and Surveillance

Kimberly Witzmann, M.D., Deputy Director

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