OTP Town Hall: CMC Readiness for Gene Therapy BLAs (Catapult’s regulatory round-up – June 2024)
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted the virtual town hall on 4th June 2024, to answer stakeholder questions regarding the chemistry, manufacturing, and controls (CMC) information submitted with biologics license applications (BLAs) for gene therapy products. Experts from OTP’s Office of Gene Therapy CMC were available to answer questions. Please find the video recording of this event here.
Published on the 3rd of July in Catapult’s regulatory round-up for June 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). OTP Town Hall: CMC Readiness for Gene Therapy BLAs (Catapult’s regulatory round-up – June 2024). ELSIBI. Consulté le 18 mars 2025 à l’adresse https://doi.org/10.58079/12mj5