PDUFA VI: Pediatrics Group Seeks Earlier And Faster Studies
American Academy of Pediatrics’ legislative proposals for user fee bill also include eliminating automatic orphan drug exemption from Pediatric Research Equity Act study requirements.
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Not A Loophole? BIO Concerned About Limiting Orphan Designations For Pediatric Subsets of Common Diseases
BIO disagrees with US FDA implying companies are behaving inappropriately, says agency should acknowledge it created problem being addressed in draft guidance.
US FDA's draft guidance closes loophole where sponsors could obtain an orphan designation for a pediatric subset and then be exempt from requirements to conduct pediatric studies.
Provisions aimed at earlier planning and completion of pediatric studies are part of user fee legislative package Senate committee will vote on May 10; measure also calls for FDA guidance on pediatric studies of molecularly targeted cancer drugs but does not require such trials.