About FDA

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

Office Director: CAPT Philip Budashewitz
Deputy Director: Vacant

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)

Page Last Updated: 02/05/2018
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