Cell Therapies and Tissue-Based Products: Generating Scientific Evidence to Facilitate Development
Office of Therapeutic Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration · July 2, 2026
Virtual FDA workshop convened by the Office of Therapeutic Products and CBER to discuss scientific evidence needs, manufacturing and potency challenges, and a proposed risk‑based framework for human cell and tissue products (HCT/Ps). Presentations and panels examined advances in pluripotent stem cells, extracellular vesicles, potency assays, and potential regulatory pathways.
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