Office of Clinical Policy

Who We Are The Office of Clinical Policy (OCLP) develops good clinical practice and human subject protection policies, regulation and guidance, and addresses key clinical policy issues across the FDA’s medical product centers. Additionally, OCLP supports guidance and policy development across medical product programs such as combination products, pediatric therapeutics and orphan product development. OCLP is comprised of the clinical policy program and the good clinical practice program. What We Do - Develop and implement clinical policy related to medical product development and regulation. - Coordinate and collaborate with offices across the FDA on timely and consistent clinical policy to advance FDA’s public health mission. - Coordinate across the FDA for good clinical practice and human subject protection regulation, international harmonization and outreach activities. - Coordinate and implement regulations, policies, operational initiatives and program priorities related to good clinical practice and human subject protection. - Advise and assist the Commissioner and other key officials across the FDA on ethical issues in clinical trials that may have an impact on policy and the safety of people participating in clinical trials. - Serve as the liaison to other federal agencies and external stakeholders to protect the rights, safety and welfare of people participating in clinical trials. - Plan and provide training to internal and external stakeholders on FDA’s good clinical practice and human subject protection policies.