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Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry." The draft document provides recommendations for next-generation sequencing (NGS)-based methods used in nonclinical studies that will likely be needed to support initiation of clinical trials of investigational human genome editing (GE) products.
- Document type
- Notice
- Federal Register document number
- 2026-07285
- Published
- Apr 15, 2026
- Action
- Notice of availability.
- Docket
- FDA-2026-D-1255
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by July 14, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- Clinical Vaccines / biologics
Source: Federal Register API, document 2026-07285. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.