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FDA – Considerations for complying with 21 CFR 211.110

The FDA has issued a draft guidance, which describes considerations for complying with the requirements in 21 CFR 211.110 to ensure batch uniformity and drug product integrity. It discusses related quality considerations for drug products that are manufactured using advanced manufacturing as well as provides recommendations on how manufacturers can incorporate process models into commercial manufacturing control strategies. Comments can be submitted until 7th April 2025.

News reported on the 31st of January 2025 in Catapult’s regulatory round-up, read the entire report here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 mai 2025). FDA – Considerations for complying with 21 CFR 211.110. ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/13yey


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