Pediatric Data Submissions: FDA Tips For Navigating Committee Review
Drug sponsors need to be pro-active and thorough in justifying their approach to pediatric studies in light of the added layer of review now conducted by the internal FDA Pediatric Review Committee, FDA's Lisa Mathis advised at the DIA annual meeting in Boston June 25
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Rather than assessing monetary penalties for violating study deadlines, H.R. 4274 directs FDA to issue warning letters and publish them on its website.
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...
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.