Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: Frequently Asked Questions—Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability, (Aug 21, 2026)

By WK Editorial Staff

The FDA 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. The guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024. (Notice, 91 Fed. Reg. 53879 (Aug. 20, 2026)).

Dates. The announcement of the guidance is published in the Federal Register on August 20, 2026.

FederalRegisterIssuances: FDAGuidanceNotices ClinicalNews DrugBiologicNews