FDA Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products (Catapult’s regulatory round-up – february 2024)
This FDA final guidance is intended to assist sponsors, including industry and academic sponsors, developing CAR T cell products by providing CAR T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design.
Published on the 5th of March 2024 in Catapult’s regulatory round-up for february 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products (Catapult’s regulatory round-up – february 2024). ELSIBI. Consulté le 19 janvier 2025 à l’adresse https://doi.org/10.58079/12mii
