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. 2012 Mar;12(3):554-62.
doi: 10.1111/j.1600-6143.2011.03976.x. Epub 2012 Feb 15.

Summary of the US FDA approval of belatacept

P Archdeacon  1 , C Dixon, O Belen, R Albrecht, J Meyer
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Free article

Summary of the US FDA approval of belatacept

P Archdeacon et al. Am J Transplant. 2012 Mar.
Free article

Abstract

Elements of the Food and Drug Administration (FDA) review of the clinical data that supported the approval of the Biologics License Application (BLA) for belatacept for prophylaxis of organ rejection in adult patients receiving a kidney transplant are summarized. The article is not intended as a comprehensive summary of the entire belatacept data submission. Rather, the discussion is meant to illustrate aspects of the FDA's process for evaluating efficacy and safety, using belatacept as an example.

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