# Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/safety-assessment-of-genome-editing-in-human-gene-therapy-products-using-next-generation-sequencing/8bd86906-9b70-4e40-ae4a-dde0c1ea99ca

> FDA guidance document: Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing. Issue date: April 14, 2026. Get complete insights and analysis.

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## Details

- Title: Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2026-04-14
- Last Changed: 2026-04-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2026-D-1255">FDA-2026-D-1255</a>

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