FDA Issues Final Guidance on Potency Assurance for Cellular and Gene Therapy Products
The FDA's final guidance offers clarity and support for the development and quality assurance of cellular and gene therapy products through a comprehensive Potency Assurance Strategy. This update marks a significant step in aligning regulatory expectations with scientific advancements in the field.
- Published date: 13-11-2026 11:01 AM
The U.S. Food and Drug Administration (FDA) released final guidance on November 2, 2026, recommending a Potency Assurance Strategy for manufacturers of cellular and gene therapy (CGT) products. This guidance is intended to ensure consistent potency throughout the development and commercialization phases of these therapies.
This updated guidance replaces the 2011 potency testing recommendations, reflecting advances in the field and addressing new challenges. It emphasizes risk-based controls tailored to the unique aspects of CGT products, such as variability in raw materials.
The document also provides recommendations for testing short-shelf-life products and patient-specific therapies, recognizing the complexities involved in maintaining potency for these specialized treatments. Manufacturers are encouraged to incorporate these strategies to support quality assurance and regulatory compliance.