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Reviewing the regulatory barriers for nanomedicine: global questions and challenges

    Diana M Bowman

    *Author for correspondence:

    E-mail Address: Diana.Bowman@asu.edu

    Sandra Day O'Connor College of Law & School for the Future of Innovation in Society, Arizona State University, Tempe, Arizona

    &
    Jake Gatof

    University of Michigan Law School, 625 S State St, Ann Arbor, MI 48109, USA

    Published Online:https://doi.org/10.2217/nnm.15.169

    Nanomedicine will play an increasing role in prevention and treatment across the entire healthcare spectrum. However, their precise market size, economic value and areas of application remain unclear. This opacity, including the question of what constitutes nanomedicine matters, especially when considered alongside the key regulatory questions and concerns. This article begins by placing these key questions into context in relation to the current scientific state of the art, focusing particular attention on the human health and safety context. In exploring these central questions surrounding the regulation of nanomedicine, this perspective also explores existing and suggested frameworks that aim to deal with emerging technologies more generally. It then outlines priority areas for action and general conclusions specific to nanomedicine.

    Papers of special note have been highlighted as: •• of considerable interest

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