BIO Comments to FDA on Pediatric Drug Development: Regulatory Considerations
July 17, 2023
BIO provides general comments and recommendations to FDA on “Complying with the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act” (Docket No. FDA-2005-D-0460-0007)
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BIO Comment Letter - FDA-2005-D-0460-0007 - Regulatory Considerations PREABCPA_FINAL
BIO Board Vice Chair and CEO of Amicus Therapeutics testified that the drug price controls in the Inflation Reduction Act harm drug research and development.
BIO provides general comments and recommendations to FDA on “Complying with the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act” (Docket No. FDA-2005-D-0460-0007)