Graft-vs-Host Product Development Guidance

FDA has published a draft guidance, Graft-versus-Host Disease: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment, to assist sponsors in developing such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 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.