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U.S. Department of Health and Human Services

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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
 
Rob Lionberger will lead the Office of Research and Standards (ORS), which includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling.
 
John Peters will lead the Office of Bioequivalence (OB), which includes the three Divisions of Bioequivalence and the Division of Clinical Review.
 
Jason Woo will lead the 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.
 
Keith Flanagan will remain as transition lead for the Office of Generic Drug Policy (OGDP), which includes the Division of Policy Development and the Division of Legal and Regulatory Support.