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  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)

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

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

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

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 the Division of Clinical Review

Nilufer Tampal, Ph.D., Acting Deputy Director

Kimberly Witzmann, M.D., Acting Deputy Director

Office of Generic Drug Policy (OGDP)

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

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 Division 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, the Division of Project Management, and the Division of Quality Management Systems.

Vacant, Deputy Director, Office of Regulatory Operations

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