FDA Guidance for Industry (Catapult’s regulatory round-up – August 2024)
FDA has issued a revised guidance providing recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) regarding the reporting and implementation of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered parenterally. This guidance also discusses pathways available to application holders to obtain Agency feedback. Additionally, this guidance discusses risk-based tools available to facilitate the implementation of changes to CCSs consisting of glass vials and stoppers.
Published on the 30th of August 2024 in Catapult’s regulatory round-up for August 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA Guidance for Industry (Catapult’s regulatory round-up – August 2024). ELSIBI. Consulté le 18 mars 2025 à l’adresse https://doi.org/10.58079/12mjs