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.
- Office of Clinical Policy (OCLiP)
- Office of Combination Products (OCP)
- Office of Orphan Products Development (OOPD)
- Office of Pediatric Therapeutics (OPT)
- Patient Affairs Staff
Office of Clinical Policy and Programs
U.S. Food and Drug Administration
10903 New Hampshire Ave, WO-32
Silver Spring, MD 20993