The International Society for Stem Cell Research (ISSCR) Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development Guidance for Industry.

The consortium, a global collaboration of academic scientists, industry leaders, and regulatory experts convened by the ISSCR, welcomed the FDA’s efforts to advance the integration of new approach methodologies (NAMs) into drug development while emphasizing the importance of maintaining a flexible, fit-for-purpose regulatory framework that can adapt to rapidly evolving technologies. ‍