Comment from International Society for Stem Cell Research
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Summary: The ISSCR Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development supports the draft guidance, commending its clear framework for integrating New Approach Methodologies (NAMs) into drug development. They provide specific recommendations to ensure the guidance remains flexible, explicitly recognizes computational and AI-integrated models, and accounts for the unique characterization needs of stem cell-derived models.
The International Society for Stem Cell Research's Consortium on on Advanced Stem Cell-Based Models in Drug Discovery and Development is submitting feedback on Docket No. FDA-2025-D-6131, General Considerations for the Use of New Approach Methodologies in Drug Development Guidance for Industry