FDA reiterates guidance plans on distributed and point-of-care manufacturing (from Catapult’s regulatory round-up – November 2023)
The FDA has reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed manufacturing (DM) and point-of-care (POC) manufacturing of drugs and biologics. FDA expects that issuing such guidance may clear up regulatory ambiguities and spur the adoption of these technologies. Please find further details here.
Published on the 5th of december 2023. Read Catapult’s entire regulatory round-up here.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (21 mai 2024). FDA reiterates guidance plans on distributed and point-of-care manufacturing (from Catapult’s regulatory round-up – November 2023). ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/11p09
