Nanomedicine: Nanotechnology, Biology and Medicine
Volume 2, Issue 2 , Pages 127-136, June 2006

Bringing nanomedicines to market: regulatory challenges, opportunities, and uncertainties

  • Ruchika Nijhara, PhD

      Affiliations

    • University of Maryland, Office of Research and Development, Baltimore, MD, United States
    • ,
  • Krishna Balakrishnan, PhD, MBA

      Affiliations

    • National Institutes of Health, Foundation for Advanced Education in the Sciences, Bethesda, MD 20814, United States
    • Corresponding Author InformationCorresponding author. One Cloister Court, Suite 230 Bethesda, MD 20814.

Received 17 February 2006; accepted 8 April 2006.

Abstract 

Scientists and entrepreneurs who contemplate developing nanomedicine products face several unique challenges in addition to many of the traditional hurdles of product development. In this review we analyze the major physicochemical, biologic and functional characteristics of several nanomedicine products on the market and explore the question of what made them unique. What made them successful? We also focus on the regulatory challenges faced by nanomedicine product developers. Based on these analyses, we propose the factors that are most likely to contribute to the success of nanomedicine products.

Key words: Nanomedicine, Product development, Commercialization, Regulations, Clinical trials, Marketing

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PII: S1549-9634(06)00045-1

doi:10.1016/j.nano.2006.04.005

Nanomedicine: Nanotechnology, Biology and Medicine
Volume 2, Issue 2 , Pages 127-136, June 2006

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