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July 26, 2007

FDA Nanotechnology Task Force Issues Report

Lynn L. Bergeson

On July 25, 2007, the Food and Drug Administration (FDA) Nanotechnology Task Force issued its report, which addresses regulatory and scientific issues and offers recommendations for each. The Task Force intends its report to outline ways for FDA to enhance its knowledge of nanotechnology to support its oversight for products using such technology, and to inform interested stakeholders what information may be needed to support the marketing of FDA-regulated products that use nanoscale materials. The Task Force recommends FDA consider developing specific guidance for manufacturers and researchers, including guidance to clarify what information should be provided to FDA about products and when the use of nanoscale materials may change the regulatory status of particular products. In its press release announcing the availability of the Task Force report, FDA states that, as with other FDA guidance, “draft guidance documents would be made available for public comment prior to being finalized.” The Task Force also recommends that FDA work to assess data needs to better regulate nanotechnology products; develop in-house expertise; ensure consideration of relevant new information on nanotechnology as it becomes available; and evaluate the adequacy of current testing approaches to assess safety, effectiveness, and quality of nanoscale materials.