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Office of Clinical Policy and Programs Also referred to as: OCPP

Who We Are

The Office of Clinical Policy and Programs (OCPP) in the Office of the Commissioner promotes safe, effective and innovative medical products for patients through agency-wide collaboration on combination products, ethical conduct of clinical research, orphan product development, patient engagement and pediatric therapeutics.

What We Do

  • Promote scientific policies that support ethical clinical trials and medical product development for adult and pediatric patients.
  • Determine orphan, rare pediatric disease, humanitarian use device and combination product designations.
  • Engage patients to learn about their experiences and help inform medical product development and regulation.
  • Administer grants for research related to orphan product and pediatric device development.
  • Coordinate safety reviews of medical products available for children.
  • Protect the rights and welfare of people participating in clinical trials.
  • Coordinate timely and effective premarket review of combination products.
  • Promote collaboration between FDA and international regulators to facilitate global pediatric drug development.

Organization

Contact Us

Office of Clinical Policy and Programs
U.S. Food and Drug Administration
10903 New Hampshire Ave, WO-32
Silver Spring, MD 20993



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