The U.S. Food and Drug Administration (FDA) has released final guidance for manufacturers of cellular and gene therapy (CGT) products. The guidance, issued on November 2, 2026, provides recommendations for a Potency Assurance Strategy to ensure products meet defined standards of potency before reaching patients.
The document replaces the FDA's 2011 potency testing guidance for CGT products. It applies to treatments for serious and often life-threatening conditions. The guidance outlines how manufacturers can verify that their products work as intended from the time of approval through post-approval monitoring.
Key recommendations include integrating potency considerations at every stage of development and commercialization. This process covers early-phase investigational new drug (IND) submissions through biologics license application (BLA) approval and continued post-market verification. Specific topics addressed include controls for variability in raw materials, testing during manufacturing, and lab tests to confirm each batch is biologically active.
The guidance also addresses specialized considerations for products with short shelf lives, viral vector gene therapies, and patient-specific therapies. The FDA stated that this approach supports faster access to safe and effective therapies for patients who often have no other treatment options.
Additionally, the FDA announced it will host a webinar on December 10, 2026, to assist stakeholders in understanding and implementing the new guidance.
