Who We Are
The Office of Clinical Policy and Programs (OCPP) in the Office of the Commissioner supports the development of clinical programs that address key policy issues across the FDA’s medical product centers. OCPP is responsible for developing, fostering, and coordinating cross-center initiatives involving the design and implementation of FDA policy related to medical product development and evaluation. The Office collectively provides leadership and coordination on complex medical product policy issues across FDA, the Department, other agencies and external stakeholders, and international bodies.
To advance the public health by developing and leading cross-cutting clinical policy and programs, in collaboration with internal and external stakeholders, to support FDA’s centers in making effective, safe, and innovative medical products available to the American people.
The Office of Good Clinical Practice (OGCP) is the focal point within FDA for Good Clinical Practice (GCP) and Human Subject Protection (HSP) issues arising in human research trials regulated by FDA. OGCP is part of the Office of Clinical Policy (OCLiP). Contact the office at: email@example.com.
The Office of Combination Products (OCP) serves as the focal point for the classification of medical products (e.g., drug, device, biological product, or combination product) and assigns a product to a lead FDA Center for review (e.g., premarket, postmarket) when the jurisdiction is unclear or in dispute. OCP also serves as a focal point for combination product issues for FDA staff and industry. Contact the office at: firstname.lastname@example.org
The Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, and medical foods) that demonstrate promise for the prevention, diagnosis, or treatment of rare diseases or orphan conditions. Contact the office at: email@example.com
The Office of Pediatric Therapeutics (OPT) mission is to assure access for children to innovative, safe and effective medical products. Contact the office at: OPT@fda.hhs.gov