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U.S. Department of Health and Human Services

About FDA

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Office of Generic Drugs: Offices and Divisions


  • Immediate Office
    • Clinical Safety Surveillance Staff
    • Program Management and Analysis Staff
    • Communications 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
    • Division of Policy Management
    • Division of Labeling Review
    • Division of Filing Review
    • Division of Quality Management Systems


Immediate Office

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

Kathleen Uhl, M.D., Acting Director, Office of Generic Drugs

Robert L. West, Deputy Director

Capt. Jason Woo, M.D., GDUFA Implementation Manager

Robert Lionberger, Ph.D., Acting Deputy Director for Science

Susan Rosencrance, Ph.D., Acting Deputy Director for Chemistry

Keith Flanagan, Regulatory Counsel

Mary Dempsey, Associate Director for Regulatory Affairs

Saundra Middleton, Senior Science Policy Analyst