Improving pediatric drug efforts
This article was originally published in The Tan Sheet
Executive Summary
FDA will launch an internal panel of experts to provide advice on pediatric studies and exclusivities, Commissioner Andrew von Eschenbach says Oct. 25. With the new Pediatric Review Committee looking over all written requests for pediatric studies, the agency expects to define more precisely the studies it wants industry to perform. The PeRC also will analyze FDA'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. It will be composed of representatives from FDA's centers for drug and for biologics evaluation and research and the commissioner's office and will meet weekly...