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USA – FDA OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls (Cell and Gene Therapy Catapult – Regulatory Round-up – August 2022)

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual town hall to answer stakeholder questions related to gene therapy chemistry, manufacturing, and controls.

The meeting will take place on Thursday 29th September, and participants can register here. Please see this FDA guidance document for more information about CMC data to support gene therapy product applications.

See all of Catapult’s Regulatory Round-up for August 2022 here.

Published on the 1st of september 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (26 octobre 2022). USA – FDA OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls (Cell and Gene Therapy Catapult – Regulatory Round-up – August 2022). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o63s


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