> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on Gene Therapy Nonclinical Info
- URL: https://www.fdaweb.com/guide-on-gene-therapy-nonclinical-info/
- Published: 2023-05-01T12:00:00.000Z
- Updated: 2026-09-14T18:28:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154338

*Federal Register* notice: FDA has announced the availability of a final guidance for industry entitled “S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.” The document provides harmonized recommendations for the conduct and overall design of such studies. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-05-01/pdf/2023-09179.pdf?ref=fdaweb.com).