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.