FDA issues final guidance on potency assurance for cell and gene therapy manufacturers

The FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products.

The guidance replaces the agency’s 2011 potency testing guidance and requires manufacturers to test each batch before patient use to confirm it meets a defined potency standard.

It applies to CGT treatments for serious or life-threatening conditions such as cancers and rare diseases, and emphasizes ongoing verification from approval through post-approval monitoring.

FDA officials said the guidance aims to give patients confidence that therapies will perform as intended and to support continued innovation in the United States.