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                Office of Clinical Policy and Programs

Office of Clinical Policy and Programs
            
                        Patient Affairs Staff
          Office of Combination Products
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          Office of Clinical Policy and Programs
          Office of Clinical PolicyOffice of Clinical Policy and Programs Office of Clinical Policy
    Also referred to as: OCLiP

    
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The Office of Clinical Policy (OCLiP) 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, OCLiP supports guidance and policy development across medical product programs such as combination products, pediatric therapeutics and orphan product development. OCLiP 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.Contact us

Email: gcpquestions@fda.hhs.gov
Phone: 301-796-8340

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

Resources

Real world evidence
	Clinical trials and human subject protection
	Clinical trials guidance documents

                                                                                  Content current as of:
      09/27/2021Office of Clinical Policy and Programs
            
          
                        Patient Affairs Staff
          Office of Combination Products
          Office of Orphan Products Development
          Office of Pediatric Therapeutics
          Office of Clinical Policy
 
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