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# Draft ICH Gene Therapy Guide
- URL: https://www.fdaweb.com/draft-ich-gene-therapy-guide/
- Published: 2021-09-09T12:00:00.000Z
- Updated: 2026-09-14T17:14:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150107

*Federal Register* notice: FDA has made available a draft guidance entitled *S12 Nonclinical Biodistribution Considerations for Gene Therapy Products*. The International Council for Harmonization document provides recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy products. It also offers considerations for interpreting and applying the BD data to support a nonclinical development program, including clinical trial designs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-09/pdf/2021-19410.pdf?ref=fdaweb.com).