# S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/s12-nonclinical-biodistribution-considerations-for-gene-therapy-products-guidance-for-industry/f0e813d3-46bd-49f2-846f-f5f95f9d4892

> FDA guidance document: S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS:  Guidance for Industry. Issue date: May 01, 2023. Get complete insights and analysis.

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## Details

- Title: S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-05-01
- Last Changed: 2023-05-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-0875">FDA-2021-D-0875</a>

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