Regulatory Blog

The US Food and Drug Administration (FDA) has issued its final guidance, Potency Assurance for Cellular and Gene Therapy Products, providing recommendations for developing a science- and risk-based strategy to ensure the potency of cellular and gene therapy (CGT) products. The guidance supersedes the January 2011 guidance on potency tests and introduces a comprehensive approach integrating manufacturing process design, material controls, in-process testing and potency assays