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# Guide on Gene Therapy Nonclinical Biodistribution
- URL: https://www.fdaweb.com/guide-on-gene-therapy-nonclinical-biodistribution/
- Published: 2021-09-13T12:00:00.000Z
- Updated: 2026-09-14T17:14:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150130

FDA has posted a draft International Conference for Harmonization [guideline ](https://www.fda.gov/media/152123/download?ref=fdaweb.com)entitled *Nonclinical Biodistribution Considerations For Gene Therapy Products* ICH S12\. The document provides harmonized recommendations for conducting nonclinical biodistribution (BD) studies for developing gene therapy products. It provides recommendations for the overall design of nonclinical BD assessments, and considerations for interpreting and applying BD data to support a nonclinical development program.

The guideline applies to gene therapy products that mediate their effect by the expression (transcription or translation) of transferred genetic materials. Some product include include purified nucleic acid (e.g., plasmids and RNA), microorganisms (e.g., viruses, bacteria, fungi) genetically modified to express transgenes (including products that edit the host genome), and ex vivo genetically modified human cells. Products that are intended to alter the host cell genome in vivo without specific transcription or translation are also covered in the document.