FDA Issues Final Guidance on Cell Therapy Potency

fact_check Facts

1. The U.S. Food and Drug Administration issued final guidance titled "Potency Assurance for Cellular and Gene Therapy Products" on November 2, 2026.

   Source: fda.gov

2. The guidance requires manufacturers of cellular and gene therapy products to implement a comprehensive, science- and risk-based plan to ensure products meet potency standards.

   Source: fda.gov

3. The guidance recommends a Potency Assurance Strategy that guides manufacturers to test and verify that every batch meets a defined standard of potency before a product reaches a patient.

   Source: fda.gov

4. The final guidance replaces the FDA's 2011 potency testing guidance for cellular and gene therapy products.

   Source: fda.gov

5. The guidance applies to treatments for serious and often life-threatening conditions.

   Source: fda.gov

6. By law, manufacturers are expected to verify that their products work as intended from the time of approval through post-approval monitoring.

   Source: fda.gov

7. The FDA will host a webinar on December 10, 2026, to help stakeholders understand and implement the guidance.

   Source: fda.gov