The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual town hall on Thursday, June 8, 2023. The event focused on cell therapy chemistry, manufacturing, and controls (CMC), including tissue-engineered medical products regulated by OTP.

The FDA requires sponsors to provide CMC information as part of an investigational new drug application. The CMC information should describe product manufacturing and testing to ensure safety, identity, quality, purity, and strength (including potency) of the investigational product. Please see this FDA guidance document or view materials from the December 2022 cell therapy CMC town hall event for more information.

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