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# Hemophilia Gene Therapy Development Guide
- URL: https://www.fdaweb.com/hemophilia-gene-therapy-development-guide/
- Published: 2020-01-30T12:00:00.000Z
- Updated: 2026-09-14T16:00:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145962

*Federal Register* notice: FDA has made available a final guidance entitled “Human Gene Therapy for Hemophilia; Guidance for Industry.” The document provides recommendations on the clinical trial design and related development for coagulation factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in activity assays. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-01-30/pdf/2020-01702.pdf?ref=fdaweb.com).