SILVER SPRING, Md., Nov. 2 -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following press release:
The U.S. Food and Drug Administration today issued final guidance for manufacturers of cellular and gene therapy (CGT) products to implement a comprehensive, science- and risk-based plan for making sure their products meet potency standards. The guidance provides FDA's recommendations for a Potency Assurance Strategy, which guides manufacturers to test and verify - before a product reaches a patient - that every batch meets a defined standard of potency to do what the product is supposed to do therapeutically.
The Potency Assurance for Cellular and Gene Therapy Products final guidance replaces FDA's ...