The evolution of public review and oversight mechanisms in human gene transfer research: joint roles of the FDA and NIH.
The federal government is critically examining its responsibilities and opportunities for bringing the new field of gene therapy to fruition and for assuring public confidence in this new area of biomedicine. The evolving mechanisms for review and regulation in human gene transfer studies in the United States are being enhanced by increasingly effective interactions between the Food and Drug Administration and the National Institutes of Health.
Friedmann
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T
Program in Human Gene Therapy and Department of Pediatrics, Center for Molecular Genetics, UCSD School of Medicine, 92093, La Jolla, CA, USA. tfriedmann@ucsd.edu
Noguchi
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P
Mickelson
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D002985:Clinical Protocols / Q000592:standards; D004274:DNA, Recombinant; D018014:Gene Transfer Techniques / Q000592:standards* / Q000639:trends; D015316:Genetic Therapy / Q000592:standards* / Q000639:trends; D006801:Humans; D009316:National Institutes of Health (U.S.); D011640:Public Policy; D014481:United States; D014486:United States Food and Drug Administration
D004274:DNA, Recombinant