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) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
US Federal Register - FDA Guidance Notices · August 20, 2026
Frequently Asked Questions—Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry
Original title: Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
FDA finalizes guidance on development of cellular and gene therapy products, addressing regulatory, manufacturing, pharmacology, clinical and pharmacokinetic questions.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.