Drugs

Office of Generic Drugs Reorganization

UPDATE [07-21-2014] Today the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) is providing an update to key leadership positions within the Office of Generic Drugs (OGD).  OGD has made assignments, most of which are in an acting capacity, to key OGD subordinate office leadership positions in preparation for October 1st – the beginning of Year 3 of GDUFA when GDUFA goal dates go into effect.

  • 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.

Kathleen “Cook” Uhl, M.D. will remain in her current role as acting director of OGD.

[12-10-2013] Today the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced the approval of plans to elevate the Office of Generic Drugs (OGD) to an office that reports directly to the center director.  This reorganization will strengthen OGD’s operations and enable the office to meet the evolving needs of generic drug review.

Generic prescription drugs make up 84% of prescriptions filled in the United States and provide affordable access to treatments for many patients and consumers. The American public depends on FDA to ensure that generic drugs perform clinically in the same way as their brand name counterparts.  The OGD reorganization is a critical and necessary step in recognizing the importance of generic drugs to public health and our national economy.

Kathleen “Cook” Uhl, M.D. will continue in her current role as acting director of OGD.  The reorganization will set in place OGD’s centralized administrative support function and project management staff for both review and policy work. The approved structure consists of the following:

  • Office of Research and Standards (includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling)
  • Office of Bioequivalence (includes three divisions of bioequivalence and a Division of Clinical Review, which includes the OGD Safety and Surveillance Team)
  • Office of Generic Drug Policy (includes the Division of Legal and Regulatory Support and the Division of Policy Development)
  • Office of Regulatory Operations (includes a Division of Project Management, a Division of Labeling Review, a Division of Filing Review, and a Division of Quality Management Systems)

This reorganization will improve generic drug regulation by streamlining processes, which will lead to greater efficiency and more consistency across review components.  The reorganization is a part of our ongoing efforts to expedite the availability of safe, effective, and high-quality generic drugs to patients. It also underscores our commitment to maintaining the public’s confidence in an Agency that continues to meet the ever-changing needs of public health.

Page Last Updated: 12/05/2014
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