FDA commissioner Andrew von Eschenbach has approved creation of an agency Pediatric Review Committee (PeRC) to provide consultation on and general review of pediatric information submitted to the FDA in pediatric plans, assessments, and studies conducted by sponsors and applicants.
A memo by deputy commissioner Janet Woodcock said PeRC will among other items: review all written requests before issuance; may review studies submitted in response to a written request to make a recommendation on exclusivity determinations; will provide consultation to reviewing divisions on all pediatric plans and assessments prior to approval of an application or supplement for which a pediatric assessment is required; and will provide review of all deferrals and waivers from the requirement to submit assessments.
Woodcock said PeRC will conduct a retrospective review and analysis of a representative sample of assessments submitted and deferrals and waivers.
From the December 01, 2007 Issue of MM+M - Medical Marketing and Media
