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

See all articles by Jordan Paradise

Jordan Paradise

Loyola University Chicago School of Law

Gail Diliberto

University of Minnesota - Twin Cities - Dept of Sociology

Alison Tisdale

University of Minnesota - Twin Cities - Dept of Sociology

Efrosini Kokkoli, PhD

University of Minnesota, Twin Cities

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.

Keywords: nanotechnology, FDA, drugs, medical devices, combination products, regulation

Suggested Citation

Paradise, Jordan K. and Diliberto, Gail and Tisdale, Alison and Kokkoli, PhD, Efrosini, Exploring Emerging Nanobiotechnology Drugs and Medical Devices. Available at SSRN: https://ssrn.com/abstract=1140749

Jordan K. Paradise (Contact Author)

Loyola University Chicago School of Law ( email )

25 E. Pearson
Chicago, IL 60611
United States

Gail Diliberto

University of Minnesota - Twin Cities - Dept of Sociology

Dept of Sociology, 909 Soc Sci Bld
267 19th Avenue South
Minneapolis, MN 55455
United States

Alison Tisdale

University of Minnesota - Twin Cities - Dept of Sociology ( email )

Minneapolis, MN 55455
United States

Efrosini Kokkoli, PhD

University of Minnesota, Twin Cities ( email )

420 Delaware St. SE
Minneapolis, MN 55455
United States

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