Pediatric research
This article was originally published in The Tan Sheet
Executive Summary
User fee exemption for pediatric drug supplements repealed under "Best Pharmaceuticals for Children Act," signed by President Bush Jan. 4. Under the law, which reauthorizes pediatric exclusivity provisions, all pediatric supplements that require clinical data for approvals, even if the supplement is for a new indication, must pay fees unless otherwise eligible for waivers. Law also directs FDA not to delay ANDA approvals based on pediatric labeling disputes (1"The Tan Sheet" Nov. 26, 2001, p. 21)...