The bench scientist’s perspective on the unique considerations in nanoparticle regulation

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.