FDA, NIH look to stream­line over­sight of gene ther­a­pies

The FDA and NIH are propos­ing to fur­ther lim­it the role of the NIH and its Re­com­bi­nant DNA Ad­vi­so­ry Com­mit­tee (RAC) in the re­view of hu­man gene ther­a­pies.

The changes, an­nounced in the Fed­er­al Reg­is­ter on Thurs­day, are aimed at re­duc­ing over­laps in the two agen­cies’ over­sight of gene ther­a­pies which re­sult in du­plica­tive work for spon­sors as the field pro­gress­es fol­low­ing the ap­proval of the first three gene ther­a­pies last year.

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