Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation S
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document entitled "Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry."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
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-04-15 |
| Summary | 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document entitled "Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry."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 number | 2026-07285 |
| Official record | https://www.federalregister.gov/documents/2026/04/15/2026-07285/safety-assessment-of-genome-editing-in-human-gene-therapy-products-using-next-generation-sequencing |