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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The American Academy of Pediatrics (AAP) wants to make pediatric study exemptions and delays harder to come by in legislation reauthorizing the US FDA’s drug user fee programs.

The professional organization is working on changes aimed at getting voluntary pediatric studies conducted under the Best Pharmaceuticals for Children...

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