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The Impact of the 21st Century Cures Act on the Regulation of Clinical Research

 

Executive Summary - February 2017

The Impact of the 21st Century Cures Act on the Regulation of Clinical Research
Carrie A. Hanger (Smith Moore Leatherwood LLP, Greensboro, NC)

Along with providing a substantial amount of funding for research, including the $1.8 billion for the Beau Biden Cancer Moonshot project, the 21st Century Cures Act makes multiple changes to the privacy and security rules relating to health information used for research purposes and to the U.S. Food and Drug Administration requirements for clinical research. This Executive Summary provides an overview of those changes.

We would like to thank the author for sharing her expertise with her colleagues.

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