title: Reviewing the regulatory barriers for nanomedicine: global questions and challenges.
abstract: 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.
authors.affiliation: Sandra Day O'Connor College of Law & School for the Future of Innovation in Society, Arizona State University, Tempe, Arizona.
authors.forename: Diana M
authors.initials: DM
authors.lastname: Bowman
authors.affiliation: University of Michigan Law School, 625 S State St, Ann Arbor, MI 48109, USA.
authors.forename: Jake
authors.initials: J
authors.lastname: Gatof
mesh_terms: D038622:Internationality; D050997:Nanomedicine
keywords: EU; USA; global challenges; governance; health and safety; innovation; intellectual property; nanomaterials; regulation