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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) is mandated by Congress. Its primary mission is to assure access for children to innovative, safe and effective medical products.  Historically, many medical products have not been tested for use in children. Pediatric product development studies require additional protection for children. Given its legislative mandate, OPT has developed five distinct yet interrelated programs to support FDA efforts to improve pediatric access.

What We Do

The OPT Scientific Activities Program works with FDA scientists and reviewers to assure that pediatric studies are rigorously designed and conducted in accord with current scientific understanding of such issues as exposure-response and extrapolation. OPT specifically reviews submitted pediatric data to develop “lessons learned” and to promote advancement of pediatric regulatory issues and science.

The OPT Ethics Program supports FDA efforts to assure that children are only enrolled in clinical studies which are both scientifically necessary and ethically appropriate.  Children should not become a mere commodity in the world market in response to FDA efforts to foster pediatric drug and biologic labeling.

The OPT Safety Program coordinates the mandated pediatric focused safety review by the Pediatric Advisory Committee for  drug and biologic products 18 months after labeling changes in response to voluntary and required pediatric studies.

The OPT International Program facilitates communication and collaboration between FDA and partner regulatory agencies around the world.  Pediatric clinical trials are necessarily global, given the incidence and distribution of diseases in the pediatric population, and thus FDA has a moral obligation to assure that children are not exposed to unnecessary, duplicative or poorly designed clinical trials world-wide.

The OPT Neonatology Program supports FDA's efforts to promote effective and safe product development for neonates and infants, by consulting with the Centers and encouraging internal and external dialogue about the unique opportunities and challenges involved in evaluating products in neonates.

Through these five distinct yet related programs, OPT works to assure timely access to medical products proven to be safe and effective for children. OPT performs this core mission in a spirit of transparency, working closely with FDA partners to optimize the use of FDA advisory committees, communicate clearly the risks and benefits of FDA-regulated products marketed for children, and assess and publish FDA experience on which our regulatory decisions are based.

Contact Us:

FDA/Office of the Commissioner
Office of Pediatric Therapeutics
White Oak Bldg.32
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Phone: 301-796-8659

Fax: 301-847-8640 


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