OTAT Town Hall Will Focus on Cell Therapy Chemistry, Manufacturing, and Controls

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) will host a virtual town hall Dec. 7 to answer questions related to cell therapy chemistry, manufacturing, and controls (CMC).

FDA requires sponsors to provide CMC information as part of an investigational new drug application. This information should describe an investigational product’s manufacturing and testing to assure safety, identity, quality, purity and strength (including potency).

The virtual town hall will take place via Zoom. Registration is required. Attendees may submit questions for the event upon registration and during the live event.