Minimizing Impact of New NIH Recombinant DNA Advisory Committee Review Process on Early Phase Human Gene Therapy Studies

By WIRB-Copernicus Group
Published: September 2017

The new NIH Guidelines for Research with Recombinant and Synthetic Nucleic Acid Molecules (the NIH Guidelines) detailing revision to the NIH Recombinant DNA Advisory Committee (RAC) process has taken effect. This paper describes the new process and strategies to minimize the impact of the changes on early phase human gene transfer studies.

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