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GUIDANCE DOCUMENT

Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products November 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

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

Submit Comments Online

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.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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