2023-21524: Graft-Versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Graft- versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drugs, biological products, and certain devices for the prevention or treatment of acute graft-versus-host disease (aGVHD) or chronic graft- vs-host disease (cGVHD). Specifically, this guidance addresses FDA's current thinking regarding the overall clinical development program and critical design elements for early and late phase trials for the intended populations. This guidance focuses on clinical trial design, statistical analysis, or other issues specific to aGVHD or cGVHD, and it does not contain a discussion of the general principles regarding statistical analysis, clinical trial design, or drug development. Additionally, this guidance is not intended to provide advice on the technical aspects of therapeutic or cell-processing devices.
The agency’s own summary, as published.
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