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NIH and FDA propose new initiatives to modernise human gene therapy oversight

NIH and FDA propose new initiatives to modernise human gene therapy oversight
August 20, 2018 SueCarr

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are proposing new efforts to encourage further advances in the rapidly evolving field of human gene therapy.

The recent proposal aims to streamline oversight of gene therapy by eliminating unnecessary duplicative reporting requirements, with human gene therapy protocols no longer being submitted to the Recombinant DNA Advisory Committee (RAC). Instead, the RAC will focus on biosafety oversight of research involving recombinant or synthetic nucleic acid molecules and review of gene therapy protocols will fall solely to the FDA, the Institutional Review Board (IRB) and the Institutional Biosafety Committee (IBC).

The revaluation of the oversight system comes after the identification of overlaps leading to “substantial duplication” in the submission of initial protocols, annual reports, amendments and reports of serious adverse events.

The NIH see the changes as an opportunity to return the RAC to its original focus – the scientific, safety and ethical issues associated with emerging biotechnologies.

For further information on the changes, take a read of the article in the New England Journal of Medicine here.