About FDA

Office of Special Medical Programs

Major Functions

  • Serves as the agency focal point for special programs and initiatives that are cross-cutting and clinical, scientific, and/or regulatory in nature.
  • Provides for the coordination of internal and external review of pediatric science, safety, ethical and international issues as mandated by law and agency activities.
  • Oversees the implementation of the orphan products provisions of the Federal Food, Drug and Cosmetic Act.
  • Provides executive leadership to the Office of Good Clinical Practice
  • Oversees the functions of the Office of Combination Products as provided in Federal Food, Drug and Cosmetic Act
  • Leads Advisory Committee Oversight and Management Staff, working in close collaboration with all FDA Centers to provide consistent operations and seek continuous improvements in the agency advisory committee program.
  • Serves as the liaison with the Office of the Secretary, the HHS Committee Management Office, all of FDA's Center advisory committee support staff, and other organizations/offices within FDA.
  • Ensures that all FDA committee management activities are consistent with the provisions of Federal Advisory Committee Act, departmental policies, and related regulations and statutes.


Contact FDA

Office of Special Medical Programs

10993 New Hampshire Avenue

WO32 - 5129

Silver Spring, MD 20993-0002

Page Last Updated: 03/28/2018
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