• Regulatory NewsRegulatory News

    FDA Outlines Regulatory Approach for Nanotechnology

    The US Food and Drug Administration (FDA) has finalized a 2011 guidance document outlining its regulatory approach for nanotechnology products, including medical products. Background As explained by FDA in the guidance, nanotechnology products—sometimes called nanomedicine—are used in a "broad array" of regulated products, such as pharmaceuticals, biologics, medical devices and dietary supplements. While the guidance loosely defines nanotechnology products as any ...
  • US Agency Releases Assessment Report on Nanotechnology, Calls for Refined Regulatory Approach

    • 30 April 2012
    The President's Council of Advisors on Science and Technology (PCAST) has released a report assessing the US's progress in implementing a broad-based program to promote the research and development of nanotechnologies, including regulatory strategies aimed at generating new medicines and technologies. One of the PCAST report's highest concerns was for workplace safety and implementing and enforcing adequate regulations to ensure manufacturing facilities are safe for work...