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

Office of Generic Drugs: Offices and Divisions

  • Immediate Office
    • Clinical Safety Surveillance Staff
    • Communications Staff
    • Generic Regulatory Affairs Team
    • Global International Affairs
    • Program Management and Analysis Staff
  • Office of Research and Standards
    • Division of Therapeutic Performance
    • Division of Quantitative Methods and Modeling
  • Office of Bioequivalence
    • Division of Bioequivalence 1
    • Division of Bioequivalence 2
    • Division of Bioequivalence 3
    • Division of Clinical Review
  • Office of Generic Drug Policy
    • Division of Legal and Regulatory Support
    • Division of Policy Development
  • Office of Regulatory Operations

 


Immediate Office

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

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

Howard D. Chazin, M.D., M.B.A., (Acting) Deputy Director, OGD

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

Bing V. Li, Ph.D., Director (Acting), Office of Bioequivalence (OB), which includes the three Divisions of Bioequivalence and the Division of Clinical Review.

Edward “Ted” Sherwood, Director, Office of Regulatory Operations (ORO), which includes the Division of Filing Review, the Division of Labeling Review, the Division of Project Management, and the Division of Quality Management Systems.

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

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