Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management October 2026

GUIDANCE DOCUMENT

Submit Comments by 11/27/2026

Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2026-D-11783

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• Docket Number: FDA-2026-D-11783
• Issued by: Center for Biologics Evaluation and Research, Office of Therapeutic Products

For a high-level overview of this guidance document, please watch this recorded webinar featuring Andrew Byrnes, PhD and Jacob Bitterman, PhD from FDA’s Office of Therapeutic Products.

This guidance is intended for sponsors and applicants developing individualized GE products. It addresses how an individualized GE product that includes multiple product variants can be submitted in a single Biologics License Application (BLA) under section 351(a) of the PHS Act. It explains how to specify the extent of GE component variation in a BLA and how to add new product variants to the BLA after licensure. This guidance also addresses related topics, including in vitro safety and potency evaluation of product variants, manufacturing process validation, labeling and indication statements, and drug naming and identification.

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