FDA Issues Final Guidance to Enhance Potency Assurance for Cell and Gene Therapy Products

The U.S. Food and Drug Administration (FDA) has released final guidance for manufacturers of cellular and gene therapy (CGT) products. This guidance outlines recommendations for a Potency Assurance Strategy, aiming to ensure that every batch of these treatments meets defined potency standards before reaching patients. This initiative is intended to provide regulatory clarity, promote innovation, and support faster access to safe and effective therapies for serious and life-threatening conditions.