April 18, 2024 at 05:44PM OTP Town Hall: CMC Readiness for Gene Therapy BLAs - 06/04/2024

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. Expe

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