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# Praise for Graft-Versus-Host Drug Guidance
- URL: https://www.fdaweb.com/praise-for-graft-versus-host-drug-guidance/
- Published: 2023-11-29T12:00:00.000Z
- Updated: 2026-09-14T14:17:16.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5155880

The American Society of Hematology says it commends FDA for releasing its draft guidance on developing products to prevent or treat graft-versus-host disease (GVHD). The society comment [letter](https://www.regulations.gov/comment/FDA-2023-D-3900-0008?ref=fdaweb.com) says investigators and hematologists conducting stem cell transplants can benefit from the guidance on acute and chronic GVHD. “To ensure that this guidance serves patients effectively and is comprehensive, it will be helpful for the agency to provide guidance on the use of composite endpoints…,” the letter says. “These endpoints are already being used in prospective studies and including them in this guidance can help sponsors feel comfortable incorporating them into future studies.”

The NIH Consensus Project on clinical trials in chronic GVHD [says](https://www.regulations.gov/comment/FDA-2023-D-3900-0006?ref=fdaweb.com) FDA “has done an outstanding job in drafting this guidance, which will be of great help to sponsors and investigators working on products for prevention or treatment of GVHD.”

In its [response](https://www.regulations.gov/comment/FDA-2023-D-3900-0005?ref=fdaweb.com), the American Society for Transplantation and Cellular Therapy says it applauds FDA for assembling the guidance.

All three commenters provide specific line-by-line comments and recommendations, as does [Sanofi](https://www.regulations.gov/comment/FDA-2023-D-3900-0009?ref=fdaweb.com).