WASHINGTON, Nov. 3 -- Food and Drug Administration has issued a notice called: Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability.
The notice was published in the Federal Register on Nov. 3 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Potency Assurance for Cellular and Gene Therapy Products." The guidance document provides recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. FDA is recommending a comprehensive approach to potency assurance of CGT pro...