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Exploring Emerging Nanobiotechnology Drugs and Medical DevicesJordan ParadiseSeton Hall University - School of Law Gail DilibertoUniversity of Minnesota - Twin Cities - Dept of Sociology Alison TisdaleUniversity of Minnesota - Twin Cities - Dept of Sociology Efrosini Kokkoli, PhDUniversity of Minnesota, Twin Cities Food & Drug Law Journal, Vol. 63, No. 2, pp. 407-420, 2008 Abstract: Nanotechnology expands across research domains, applications and products and remains a field with neither a single scientific definition nor a formal regulatory or statutory definition. However, health and medical applications are burgeoning. This article examines the field of nanomedicine in order to highlight existing products and future applications now in research and development phases. We present existing oversight mechanisms for products in the drug and device realm; specifically examine nanodrugs and nanodevices approved by the FDA; and highlight emerging nanoproducts that may pose a challenge for current regulatory schemes both in the U.S. and internationally.
Number of Pages in PDF File: 15 Keywords: nanotechnology, FDA, drugs, medical devices, combination products, regulation Accepted Paper SeriesDate posted: June 5, 2008Suggested CitationContact Information
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