NIH Ends Gene Therapy Trial Reporting Requirements In Reg Streamlining Move

Trial protocols, annual reports, and adverse event reports on gene therapies now only go to US FDA, a signal that the products can be regulated like other drugs and biologics.

The decision by the US National Institutes of Health to streamline its regulation of gene therapy clinical trials is a recognition that the category has entered the treatment mainstream.

Under a proposal announced Aug. 16, NIH's Recombinant DNA Advisory Committee (RAC) would stop receiving and reviewing initial trial protocols,...