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# FDA Draft Guide on Delayed Graft Function in Kidney Transplants
- URL: https://www.fdaweb.com/fda-draft-guide-on-delayed-graft-function-in-kidney-transplants/
- Published: 2017-03-22T12:00:00.000Z
- Updated: 2026-09-14T22:13:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138265

FDA has released a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM547955.pdf?ref=fdaweb.com) on “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention,” which addresses the agency’s current thinking on the overall development program and clinical trial designs for systemic drugs administered to kidney transplant recipients to support an indication of prevention of delayed graft function (DGF). The agency says the document is “intended to serve as a focus for continued discussions among the Division of Transplant and Ophthalmology Products, pharmaceutical sponsors, the academic community, and the public.” It does not address DGF treatment in the recipient, or the treatment of the donor or the graft for the purpose of preserving or improving graft quality. The agency notes that these issues may be addressed in separate upcoming guidances.