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Navigating FDA’s Approach to Approval of Nanoparticle-Based Drugs and Devices
Volume 8, Issue 4

Mark N. Duvall, Alexandra M. Wyatt and Felix S. Yeung

Nanoparticle-based drugs, devices, and combination drug-device products have great potential for improving medical treatment and outcomes. However, the U.S. Food and Drug Administration’s (FDA) framework for reviewing, approving and regulating drugs and devices poses special chal-lenges when applied to medical products that incorporate nanotechnology. Categorization of combination products as either drugs or devices is an important threshold step with potentially significant impacts on the costs and feasibility of bringing a product to market. However, categorization is complicated by some of the scientific issues unique to materials at the nanoscale. The regulatory complexities continue once a nanotechnology-based product has been slated for FDA’s regulatory review under the regimes for either drugs or devices. This article provides an overview of FDA’s current approach in each of these areas: categorizing, reviewing, approving, and regulating nano-technology-based combination products, prescription drugs, and devices. It also points out areas of uncertainty given nanotechnology’s unique characteristics, and the lack of robust scientific information about their environmental, health, and safety risks. The article concludes that FDA’s approach toward nanotechnology in drugs, devices, and combination drug-device products will likely change as more information become available.

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