FDA Unveils FAQ Bible for Budding Gene and Cell Therapy Makers
Published Date: 8/20/2026
Notice
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) 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 This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Final FAQ Guidance for CGT Sponsors
The FDA published a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products" on August 20, 2026, which finalizes the draft dated November 19, 2024. The guidance gives sponsors answers to common development questions across regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology to support development and increase efficiency under the PDUFA VII commitment.
No New Paperwork Burden Declared
The guidance states it contains no new collection of information under the Paperwork Reduction Act. It refers to previously approved FDA information collections with OMB control numbers 0910-0014 and 0910-0338 covering investigational new drug applications, clinical trials and related forms (e.g., Form FDA 1571, Form FDA 3674, Form FDA 356h).
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