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# Graft-vs-Host Product Development Guidance
- URL: https://www.fdaweb.com/graft-vs-host-product-development-guidance/
- Published: 2023-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:58:59.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5155436

FDA has published a draft guidance, *Graft-versus-Host Disease: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment*, to assist sponsors in developing such products. Specifically, the [document](https://www.fda.gov/media/172524/download?ref=fdaweb.com) addresses the agency’s current thinking about the overall clinical development program and critical design elements for early- and late-phase trials for the intended populations.

The guidance is not intended to provide advice on the technical aspects of therapeutic or cell-processing devices, FDA says. It says feedback on the technical aspects of the devices may be requested through a presubmission meeting with the appropriate Center.

The guidance has an Introduction, Background, Development Programs (general drug development considerations, prevention of graft-versus-host disease (GVHD), treatment of acute GVHD, and treatment of chronic GVHD), Marketing Applications, and five Appendices.