FDA 发布细胞与基因治疗产品开发常见问题行业指南（2026年8月定稿）
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products; Guidance for Industry
美国 FDA 生物制品评价与研究中心（CBER）发布行业指南《Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products》，2026年8月定稿，Docket Number 为 FDA-2024-D-4311。
FDA 以问答形式梳理 CGT 产品开发中监管审评、CMC、药理毒理与临床等环节的常见问题，便于对照自身开发阶段。
GUIDANCE DOCUMENT
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products Guidance for Industry August 2026
Final
- Docket Number:
- FDA-2024-D-4311
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
This guidance is intended to provide industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products and is intended to help facilitate the development of safe, effective, and high-quality 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 (PT), clinical, and clinical pharmacology.
In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2024-D-4311.
来源：FDA · 细胞与基因治疗监管 · fda.gov