The emergence and use of nanotechnologies in commercially available products, including nanotherapeutics, have necessitated the response of regulatory agencies to ensure that these products are safely employed. While bench scientists are at the forefront of nanoparticle development and design, many are unaware of the regulatory requirements necessary to transform their laboratory discoveries into marketable products. As bench scientists, we performed a "thought experiment" using multifunctional mesoporous silica nanoparticles synthesized in our lab, which we considered as a combination product, to try to understand the steps necessary for pre-clinical approval from the Food and Drug Administration. This thought experiment illuminated challenges associated with nanoparticle risk assessment and regulation.
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Acknowledgments Preparation of this article was supported by National Science Foundation (NSF) grant #0608791, ‘‘NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context’’ (Principle Investigator: S.M. Wolf; Co-PIs: E. Kokkoli, J. Kuzma, J. Paradise, and G. Ramachandran). This study was financially supported by NSF grant # CHE-0645041, an NSF Graduate Research Fellowship awarded to M.A.M.-J., and a Taiwan Merit Scholarship (NSC-095-SAF-I-564-052-TMS) awarded to Y.-S.L. The views expressed are those of the authors and do not necessarily reflect the views of NSF.