Memorandum of Understanding Between the Food and Drug Administration and Duke University

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The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Duke University. The purpose of this MOU is to establish the terms of collaboration between FDA and Duke, beginning with an initiative to strengthen Human Subjects Protection by reexamining and modernizing the conduct of clinical trials to ensure that design, execution, and analysis are of optimal quality. To this end, Duke will be the convener of a Public Private Partnership, to which FDA will be a founding partner, to systematically modernize the clinical trial process.