Town Hall | Virtual

Scheduled

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual town hall on Tuesday, April 25, 2023. This event focused on gene therapy chemistry, manufacturing, and controls. 

Gene therapy-related research and development continues to grow rapidly, resulting in an increasing number of products being evaluated in late-stage clinical studies in support of product licensure. The FDA requires sponsors to provide information about chemistry, manufacturing, and controls (CMC) as part of investigational new drug, biologics license, and new drug applications. For gene therapies and other biologic products, the CMC information should describe the sponsor’s commitment to perform manufacturing and testing to assure product safety, identity, quality, purity, and strength (including potency). For more information, see the FDA gene therapy CMC guidance document or view materials from the September 2022 gene therapy CMC town hall event.

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