NIH Proposes Limiting Advisory Committee Role In Gene Therapy Oversight

The National Institutes of Health and FDA are taking steps to streamline their oversight of gene therapy by limiting the role of NIH and its Recombinant DNA Advisory Committee (RAC) in overseeing human gene transfer (HGT) clinical research protocols. In a commentary published in the New England Journal of Medicine , the heads of both agencies say a long-standing overlap in oversight between NIH and FDA is no longer needed because there is not “sufficient evidence to claim that the...