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U.S. Department of Health and Human Services

Drugs

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Issues in the Development of Medical Products for the Prophylaxis/Treatment of Acute Antibody Mediated Rejection (AMR) in Kidney Transplant Recipients; Public Workshop, June 28- 29, 2010

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of medical products (i.e., human drugs, therapeutic biological products, and medical devices) for prophylaxis and/or treatment of acute antibody mediated rejection (AMR) in kidney transplant recipients. This public workshop is intended to provide information for and gain perspective from health care providers, academia, and industry on various aspects of development of medical products for prophylaxis and/or treatment of acute AMR in kidney transplant recipients, including clinical trial design and endpoints. The input from this public workshop will help in developing topics for further discussion and may serve to inform the agency in a future goal of developing a Guidance to Industry document on developing products for the prophylaxis and/or treatment of acute AMR rejection in kidney transplant recipients.