CMC Flexibilities for Developing Human Cell and Gene Therapy Products for a BLA
Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration · July 7, 2026
Webinar by FDA CBER leaders explaining a May 2026 guidance that consolidates CMC flexibilities for developers of human cellular and gene therapy products preparing Biologics License Applications (BLAs). Presenters outlined four categories of flexibility, examples, and encouraged early engagement with review teams.
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