BIO Comments to the FDA on the Agency’s Updated Guidance on PREA and BPCA
July 17, 2023
BIO provides general comments and recommendations on FDA’s Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act (Docket No. FDA-2005-D-0460-0008)
Download Full Comments Below
BIO Comment Letter - FDA-2005-D-0460-0008 - Scientific Considerations PREABCPA_FINA
BIO provides detailed comments in advance of the July 31, 2023 NIH Workshop, “Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer.
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BIO provides general comments and recommendations on FDA’s Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act (Docket No. FDA-2005-D-0460-0008)