FDA to Host Virtual Town Hall on Gene Therapy Manufacturing

September 11, 2025

The Office of Therapeutic Products (OTP) within FDA’s Center for Biologics Evaluation and Research (CBER) will host a virtual town hall on Oct. 22 to provide guidance on chemistry, manufacturing and controls (CMC) and facility readiness for gene therapy biologics license application (BLA) submissions. The program will include experts from OTP’s Office of Gene Therapy and CBER’s Office of Compliance and Biologics Quality’s Division of Manufacturing and Product Quality to answer stakeholder questions.

The town hall will take place from 12 to 1:30 p.m. ET. Registration is free and open to the public.