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FDA ALONE WILL RECEIVE GENE TRANSFER PROTOCOL SUBMISSIONS

Executive Summary

FDA ALONE WILL RECEIVE GENE TRANSFER PROTOCOL SUBMISSIONS under proposed reforms that consolidate FDA and National Institutes of Health procedures for gene therapy protocol reviews. Under the proposal, published in the Aug. 23 Federal Register, "investigators will no longer be required to provide a separate submission" to NIH's Office of Recombinant DNA for review by the Recombinant DNA Advisory Committee. FDA's Division of Cellular and Gene Therapies will forward a copy of each submission to NIH/ORDA.
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