> ## 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.

# Draft Guide on Gene Therapy Sameness
- URL: https://www.fdaweb.com/draft-guide-on-gene-therapy-sameness/
- Published: 2020-01-30T12:00:00.000Z
- Updated: 2026-09-14T16:00:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145964

*Federal Register* notice: FDA has made available a draft guidance entitled “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.” The document provides FDA’s current thinking on the criteria to determine sameness of human gene therapy products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-01-30/pdf/2020-01705.pdf?ref=fdaweb.com).