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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
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  3. FDA Organization
  4. Center for Drug Evaluation and Research (CDER)
  5. CDER Offices and Divisions
  6. Office of Medical Policy Initiatives (OMPI)
  1. CDER Offices and Divisions

Office of Medical Policy Initiatives (OMPI)

Office Location:

10903 New Hampshire Avenue, Building 51
Silver Spring, MD 20993

Phone and Fax Numbers:

Phone: 301-796-2500
Fax: 301-847-3529

What We Do

  • Provides oversight and direction for the development of medical policies and procedures pertaining to the drug development and drug approval processes, bioresearch monitoring, and human subject protection.
  • Provides oversight and direction for new and ongoing policy initiatives in broad-based medical and clinical policy areas, including initiatives to improve the science and efficiency of clinical trials, promote clinical trial quality, and collaboratively enhance professional and patient labeling.
  • Provides oversight and direction for research and other programs and initiatives to support and advance medical policy development.

Office Organization

  • Division of Medical Policy Programs (DMPP)
  • Division of Medical Policy Development (DMPD)
  • Division of Clinical Trial Quality (DCTQ)


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