OTP Town Hall: CMC Readiness for Gene Therapy BLAs JUNE 4, 2024

https://www.fda.gov/news-events/otp-town-hall-cmc-readiness-gene-therapy-blas-06042024?utm_medium=email&utm_source=govdelivery The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Tuesday, June 4, 2024, to answer stakeholder questions regarding the chemistry, manufacturing, and controls (CMC) information submitted with biologics license applications (BLAs) for gene therapy products. Experts from OTP’s Office of Gene Therapy CMC will be on hand to answer questions.