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FDA Accelerated approval – expedited program for serious conditions (from Catapult’s regulatory round-up for December 2024)

FDA has issued a draft guidance to provide information on FDA’s policies and procedures for accelerated approval as well as threshold criteria for whether a drug is a candidate for accelerated approval. This guidance also describes the procedures for expedited withdrawal of approval of a product approved under accelerated approval and the revisions Congress made through the Consolidated Appropriations Act, 2023 (Public Law 117-328). The deadline for comments is 4th February 2025.

Published on the 9th of January 2025. Read the entire Regulatory Round-up – December 2024.

 

 


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (12 février 2025). FDA Accelerated approval – expedited program for serious conditions (from Catapult’s regulatory round-up for December 2024). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/13ay0


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