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U.S. Department of Health and Human Services

Drugs

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Effects of Ischemia Reperfusion Injury on Outcomes in Kidney Transplantation; Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop to discuss the effects of ischemia/reperfusion injury (IRI) on outcomes in kidney transplantation. This public workshop is intended to obtain information from health care providers, academia, and industry on various aspects of the pathophysiology, clinical management, and outcomes following IRI. The meeting will include a  discussion of animal models, devices, and clinical trial design. The input from this public workshop will help in developing topics for further discussion and may serve to inform recommendations on clinical trial  design for products for the mitigation of IRI and/or for the prophylaxis and/or treatment of delayed graft function (DGF) and related conditions in kidney transplant recipients.

Date and Time:  This two day meeting will be held on Thursday, September 8, 2011 from 9:00 a.m. to 6:00 p.m., and Friday, September 9, 2011 from 8:00 a.m. to 3:00 p.m.

Location:  Crowne Plaza, 8777 Georgia Avenue, Silver Spring, Maryland