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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
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