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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

On January 8, 2021, FDA announced the approval of a reorganization of the Office of Generic Drugs. The new structure will strengthen OGD’s operations and allow the office to meet the evolving needs of generic drug review while upholding the FDA’s international reputation as the gold standard in the assessment and monitoring of generic drugs. Relevant changes to Offices and Divisions on this page will be updated once the reorganization is in effect.

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.

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

Sarah Ibrahim, Ph.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.

LCDR Malik Imam, Pharm.D., Deputy Director

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