> ## 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.

# Gene Products Editing Guidance
- URL: https://www.fdaweb.com/gene-products-editing-guidance/
- Published: 2022-03-15T12:00:00.000Z
- Updated: 2026-09-14T17:36:34.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151365

FDA has published a draft guidance, *Human Gene Therapy Products Incorporating Human Genome Editing*, with recommendations for sponsors developing human gene therapy products incorporating genome editing of human somatic cells. Specifically, the [document](https://www.fda.gov/media/156894/download?ref=fdaweb.com) provides recommendations about the information that should be provided in an IND application to assess the safety and quality of the investigational genome editing product. FDA says the information includes product design, product manufacturing, product testing, preclinical safety assessment, and clinical trial design.

The guidance covers Introduction, Background, Considerations for Product Development, Considerations for Preclinical Studies, Considerations for Clinical Studies, Communication with FDA, References, and an Appendix.