# Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/leveraging-prior-knowledge-in-the-development-of-human-gene-therapy-products-incorporating-genome-editing/4ed1473e-e7aa-43b9-89a0-6a6910525833

> FDA guidance document: Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing. Issue date: June 02, 2026. Get complete insights and analysis.

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## Details

- Title: Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing
- 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: 2026-06-02
- Last Changed: 2026-06-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2026-D-1257">FDA-2026-D-1257</a>

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