Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry

Issue Date: July 29, 2019
Issued by: Center for Biologics Evaluation and Research
Topic(s): Clinical – Medical
Status: Final

Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for systemic drugs administered to the kidney transplant recipient to support an indication of prevention of DGF.

Download the Guidance Document

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