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  1. Office of Clinical Policy and Programs

Office of Pediatric Therapeutics Also referred to as: OPT

Who We Are

The Office of Pediatric Therapeutics (OPT) helps assure access for children to innovative, safe and effective medical products.

What We Do

  • Work with scientific experts across the FDA to help assure pediatric studies are designed and conducted according to current scientific principles to inform medical product development, review and decision making.
  • Help assure children are only enrolled in clinical studies that are scientifically necessary and ethically appropriate.
  • Engage international regulators to help assure children around the world participate in clinical trials that meet international regulatory standards so pediatric trials are not needlessly repeated.
  • Coordinate the FDA’s Pediatric Advisory Committee to obtain independent expert advice on scientific, clinical, technical and policy matters surrounding pediatric research.
  • Coordinate pediatric safety reviews by the Pediatric Advisory Committee for certain medical products marketed for children.
  • Promote development of safe and effective medical products for neonates and infants by encouraging and supporting the FDA’s medical product centers as we address the unique opportunities and challenges involved in evaluating products in neonates.
  • Collaborate across the agency to designate diseases for the FDA’s rare pediatric disease designation program to encourage development of new medical products for rare pediatric diseases. .

Contact Us:

Email: OPT@fda.hhs.gov
Phone: 301-796-8659
Fax: 301-847-8640 

Office of Pediatric Therapeutics
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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