Exploring Emerging Nanobiotechnology Drugs and Medical Devices
Food & Drug Law Journal, Vol. 63, No. 2, pp. 407-420, 2008
15 Pages Posted: 5 Jun 2008
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.
Keywords: nanotechnology, FDA, drugs, medical devices, combination products, regulation
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