Recombinant DNA Advisory Committee regulatory update

The amended guidelines will mean a considerable savings in review time for companies involved in certain areas of research, such as cancer and immunostimulation, according to Robert Abbott, president and CEO of Viagene Inc.

RAC also voted to establish an accelerated review process for certain categories of gene transfer experiments. The decision allows the NIH Office of Recombinant DNA Activities to assign a review category to all human gene transfer proposals, and establish which categories of human gene transfer experiments qualify for accelerated review or exemption from review. ...