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  • Feature ArticlesFeature Articles

    Regulation and Oversight of Gene Therapy in the US

    This article discusses the evolution, potential uses and regulatory aspects of gene therapy and includes funding, delivery mechanisms, bioethics and steps toward clinical trial implementation. Introduction Sponsors and investigators need to be prepared to take specific steps to satisfy FDA and NIH requirements before, during and after clinical trial implementation. There are a significant number of guidance documents and internal procedures aimed at helping to prepare...