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The Regulatory and Liability Implications of Nanoscale Drug Delivery in the Human Body
Volume 11, Issue 1

Shane McNamee

In this article, researcher Shane McNamee addresses the practical, legal, and regulatory implications of nanoscale drug delivery. Some of the technical and legal challenges that impact current drug delivery methods (e.g., ingestion and injection) also apply to new nanoscale methods. But, the scale and scope of application in nanotechnologies raises additional issues. This article first analyzes the general novel characteristics and health risks of nanoparticles, as well as specific issues of insertion, removal, and informed consent. Then the article considers how the actual in-vivo use of nanoscale drug delivery could practically affect legal liability. Finally, this article takes a broader look at the regulation of nanotechnology in general, how this might apply to nanoscale drug delivery, and what steps may need to be taken to further regulate this area.

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