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FDA’s Final and Draft Nanotechnology Guidance Documents: No Big Surprises
Volume 12, Issue 1

Lynn L. Bergeson and Carla N. Hutton

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidance documents and one draft guidance document that FDA believes will provide greater regulatory clarity for industry and other stakeholders on the use of nanotechnology in FDA-regulated products. In this article, Lynn Bergeson and Carla N. Hutton review the recent guidance and highlight important considerations.

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