Last December, nearly 40 professionals with the U.S. Food and Drug Administration (FDA) gathered with ISSCR leaders to discuss advances in the development of stem cell therapies. The attendance of FDA leaders – Peter Marks, Director, Center for Biologics Evaluation and Research (CBER), Celia Witten, Deputy Director, CBER, and Wilson Bryan, Director, Office of Tissues and Advanced Therapies (OTAT) – signals how important it is for the agency to discuss scientifically informed recommendations from the ISSCR as new stem cell-based therapies advance.