India, Nov. 3 -- The U.S. Food and Drug Administration has issued final guidance for manufacturers of cellular and gene therapy 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 2011 potency testing guidance for CGT products and applies to treatments for serious and often life-threatening conditions. By law, ...