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OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs

Office of Therapeutic Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration · July 23, 2026

The FDAs Office of Therapeutic Products hosted a virtual town hall on CMC expectations and readiness for late-stage INDs for cell therapy and tissue-engineered products, answering pre-submitted and live questions from product developers and researchers.

AI-Generated Content: All content on this page was generated by AI to highlight key points from the meeting. For complete details and context, we recommend watching the full video. so we can fix them.