What the FDA's New Framework Means for Regenerative Therapies

Earlier this month, the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products. The framework spells out how the FDA intends to review new products and protect patient safety in this emerging area that FDA Commissioner Scott Gottlieb called “dynamic and complex” with “unique challenges.” We spoke to Michael Werner, executive director of the Alliance for Regenerative Medicine, about the framework, whether it provides the clarity industry sought, and what it will mean for patients hoping to see safe and effective regenerative therapies reach them as quickly as possible.