Pediatric Review Committee

Executive Summary

An internal panel of experts will provide advice on pediatric studies and exclusivities, FDA announces Oct. 25. Plans to have the new Pediatric Review Committee look over all written requests for pediatric studies prior to their issuance could help the agency define more precisely the studies it wants industry to perform (1"The Pink Sheet" July 2, 2007, p. 8). PeRC, which will be composed of representatives from CDER, CBER and the Commissioner's Office and will initially meet weekly, will also analyze the agency's past performance in implementing provisions of the Pediatric Research Equity Act concerning assessments of a drug's efficacy and safety in the pediatric population...