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August 23, 2011

FDA Regulatory Science Plan Addresses Nanomaterials and Nanotechnology

Lynn L. Bergeson

The U.S. Food and Drug Administration (FDA) released on August 17, 2011, a document entitled Advancing Regulatory Science at FDA: A Strategic Plan. FDA states that its core responsibility is to protect consumers by applying the best possible science to its regulatory activities.  FDA notes that rapid advances in innovative science have provided new technologies to discover, manufacture, and assess novel medical products, and to improve food safety and quality. To keep pace with and use these new scientific advances, FDA developed the Strategic Plan. According to the Strategic Plan, one of the ways FDA intends to support new approaches to improve product manufacturing and quality is by developing new analytical methods, including improved methods and tools to detect and measure the physical structure, chemical properties, and safety of engineered nanomaterials in FDA-regulated products. The priority area entitled “Ensure FDA Readiness to Evaluate Innovative Emerging Technologies” includes the following statement regarding nanotechnology:

As medical products are being revolutionized by cutting-edge technologies like nanotechnology, it is more critical than ever for FDA to fully understand how nanomaterials are being used in these products.  FDA has established Nanotechnology Core Centers to provide critically needed equipment and technical staff to conduct product assessment and safety research in support of regulatory decision making.  These centers will facilitate investigations on the safety of products that use nanomaterials, establish methods to assess quality and effectiveness of products that use nanomaterials, and identify standards to be incorporated in the preclinical safety assessment of products that contain nanomaterials.