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