FDA issues final guidance on potency standards for cell and gene therapy developers

The U.S. Food and Drug Administration released a final guidance on Monday that sets out the expectations for sponsors of cell and gene therapies to demonstrate product potency.

The document requires developers to create a potency assurance strategy, including validated assays, clear documentation, and controls to confirm consistent activity of their products.

The agency says the clarified requirements are intended to streamline regulatory review and help bring safe, effective CGT treatments to patients more efficiently.