FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: FREQUENTLY ASKED QUESTIONS-DEVELOPING POTENTIAL CELLULAR AND GENE THERAPY PRODUCTS; FINAL GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Aug. 20 -- Food and Drug Administration has issued a notice called: Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability.

The notice was published in the Federal Register on Aug. 20 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 "Frequently asked Questions-Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) pr...