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# Guide on Genome Editing Gene Therapies
- URL: https://www.fdaweb.com/guide-on-genome-editing-gene-therapies/
- Published: 2024-01-30T12:00:00.000Z
- Updated: 2026-09-14T14:21:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156247

*Federal Register* notice: FDA is making available a final guidance entitled “Human Gene Therapy Products Incorporating Human Genome Editing.” The document provides recommendations to sponsors developing human gene therapy products incorporating genome editing of human somatic cells. It also discusses the information that should be provided in an IND application to assess the safety and quality of the investigational product, including information on product design, product manufacturing and testing, nonclinical safety assessment, and clinical trial design. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-01-30/pdf/2024-01788.pdf?ref=fdaweb.com).