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USA FDA releases of 2 draft guidances on Pediatric Drug Development ( Catapult’s regulatory round-up May)

The FDA has announced the availability of the Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act Guidance for Industry draft guidance and the Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations draft guidance which address selected clinical, scientific, and ethical issues involved in developing drugs, including biological products, for pediatric use when such drug products are subject to the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). These draft guidance documents are intended to assist industry in obtaining the data and information necessary to support the approval of drug products in pediatric populations.

Published on the 2nd of June 2023. Read the entire regulatory round-up for the month of May published and curated by Catapult here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 février 2024). USA FDA releases of 2 draft guidances on Pediatric Drug Development ( Catapult’s regulatory round-up May). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/vvd3


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