FDA Establishes Pediatric Review Committee

November 1, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration announced the formation of the Pediatric Review Committee to help ensure quality and consistency across the agency.

Rockville, MD (Oct. 26)-The US Food and Drug Administration announced the formation of the Pediatric Review Committee (PeRC) to help ensure quality and consistency across the agency. PeRC will provide consultation and review pediatric information that applicants submit to FDA in pediatric plans, assessments, and studies. PeRC will also review deferrals and waivers granted under section 505B of the Federal Food, Drug, and Cosmetic Act.

PeRC’s duties will include:

  • Reviewing studies to make recommendations about exclusivity determinations

  • Providing consultation to reviewing divisions on all pediatric plans and assessments before applications or supplements are approved

  • Making recommendations to reviewing divisions about to whether supplements should be considered for priority review

  • Helping to track and make publicly available information about pediatric studies and labeling changes.

PeRC is scheduled to conduct a retrospective review and analysis of a representative sample of assessments, deferrals, and waivers approved since the enactment of the Pediatric Research Equity Act of 2003.

Deputy Commissioner Janet Woodcock proposed establishing PeRC with the Center for Drug Evaluation and Research (CDER) as the committee’s designated lead. The committee’s members will include representatives from CDER, the Center for Biologics Evaluation and Research, and the Office of the Commissioner. PeRC’s members will have expertise in pediatrics, biopharmacology, statistics, chemistry, legal issues, and pediatric ethics.

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