FDA and NIH to loosen oversight of gene therapy development | DuchenneXchange

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FDA and NIH to loosen oversight of gene therapy development


Citing the need to safely expedite the development of gene therapies and the rapid scientific advances related to the gene editing, the FDA and NIH are backing trimmed down oversight of relevant clinical trials, specifically eliminating the duplication of oversight related to initial study protocols, annual reports, amendments and serious adverse event reporting. Senior leaders in both organizations believe that there is no longer sufficient evidence to assert that the risks of gene therapy are entirely unique and unpredictable or that the field requires special oversight over and above the existing framework.

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