• 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 ...
  • Safety of Nanotechnology Focus of New EMA, MHLW Joint Reflection Paper

    The European medicines Agency (EMA) has released a new draft reflection paper on the development of nanomedicines made with block copolymer micelles (BCMs), aiming to provide basic information for the development of a common type of investigational nanomedicine. The paper is unusual in that it is being developed alongside Japan's Ministry of Health, Labour and Welfare (MHLW), the parent organization of the Pharmaceuticals and Medical Devices Agency (PMDA). Between EMA an...
  • 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...
  • Hamburg: Nanotechnology Regulation Likely to Become 'More Nuanced,' Outlines Regulatory Approach

    • 23 April 2012
    After releasing new nanotechnology standards for food and cosmetic products, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg says the agency's approach to the regulation of nanotechnology products is likely to become "more nuanced" over time. Writing in the journal Science , Hamburg writes the agency has "long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies." "Nanotechnology is not unique in thi...
  • First Targeted Nanomedicine to Enter Clinical Trials

    • 10 April 2012
    A diverse team of scientists, engineers and physicians from seven US-based institutions are preparing to study the first targeted nanomedicine in humans after the medicine was found to have "promising effects" in treating solid tumors, the group said in a press release. The result of the team's nonclinical work was published in the journal Science Translational Medicine , which found the treatment to be highly effective against the tumors, particularly relative to exist...
  • Feature ArticlesFeature Articles

    Nanomedicine: Current Regulatory Scenario and Prophylactic Regulatory Strategies

    "According to Global Industry Analysts Inc. report on nanomedicine, commercialization of this tiny technology is surging at a steady rate and is expected to exceed $160 billion by 2015." 1 What is Nanomedicine? In simple terms, nanomedicine (NM) is nanotechnology-enabled medicine. 2 It is the science and technology of diagnosing, curing and preventing a disease, repairing damaged tissues and preserving human health using molecular tools and molecular knowledge of the ...