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FDA SHOULD CONDUCT MOST REVIEWS OF GENE THERAPY PROTOCOLS, WHILE NIH RAC SHOULD CONTINUE AS POLICY BODY -- AD HOC GROUP; DATABASE DEVELOPMENT SUPPORTED

Executive Summary

FDA should be responsible for the review of most individual gene therapy protocols, while the National Institutes of Health Recombinant DNA Advisory Committee should devote more attention to policy, RAC Ad Hoc Review Committee Chair Inder Verma, PhD, the Salk Institute, asserted at the group's final meeting Aug. 28.
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