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  • Regulatory NewsRegulatory News

    Nanomaterials: FDA Issues Draft Guidance for Drugs and Biologics

    The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing a risk-based framework for drugs and biologics containing nanomaterials or made using nanotechnology. According to the agency, nanomaterials can perform a variety of functions in drug products, such as improved targeting of a particular organ or increased bioavailability. FDA says it does not "categorically judge" drugs and biologics containing nanomaterials to be "intrinsically benign o...
  • Regulatory NewsRegulatory News

    Small Regulation: FDA Adopts Three Nanotechnology Standards in Last Year

    The US Food and Drug Administration (FDA) has just adopted a new standard on the use of nanotechnology in medical devices—only its third nanotechnology standard yet adopted. Background The new standard, Surface Characterization Of Gold Nanoparticles For Nanomaterial Specific Toxicity Screening: FT-IR Method , was released on 27 January 2015 as part of a major update to FDA's List of Recognized Standards . The standards adopted by FDA are something of a deviation from...
  • Regulatory NewsRegulatory News

    Anvisa to Develop Standards and Guidelines for Nanotechnology Products

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil’s national regulatory agency, Anvisa, has established a multidisciplinary Nanotechnology Committee within the agency with the mandate to develop standards and specific guidelines for the evaluation and regulation of products that use nanotechnology.  In additio...
  • 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 ...
  • Brazil's Anvisa Renews Focus on Nanotechnology

    Brazil's National Agency for Sanitary Surveillance (Anvisa) renewed its cooperation agreement on 9 September 2013 with the country's National Council for Scientific and Technological Development (CNPq).  The renewal particularly foresees cooperative research on the use of nanotechnology in products of interest to health and whether there is a need for regulation targeting such products.  The objective is to fill the existing gaps in scientific technolog...
  • 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...
  • Brazilian Regulators: Development, Oversight of Nanotechnology Products a Priority

    Brazil's National Health Surveillance Agency (Anvisa) met on 31 October 2012 to discuss the potential impact of nanotechnology on various fields, including medicines and biology, and how the technology could be used to benefit the country's national strategic priorities on public health and industrial development. The use of nanotechnology has been associated with potential risks to human health, and Anvisa regulators made clear that the agency sees its role as both a ...
  • FDA Plans to Focus on Tablet Scoring, Nanotechnology at Upcoming Meeting

    • 13 July 2012
    The US Food and Drug Administration (FDA) plans to address tablet scoring and nanotechnology topics at an upcoming meeting in August 2012, the agency said. In a 13 July 2012 Federal Register posting announcing the meeting, FDA explained that the meeting's topics will include proposed draft guidance on tablet scoring released in August 2011 entitled, Tablet Scoring: Nomenclature, Labeling and Data for Evaluation . The draft guidance directs sponsors of New Drug Appl...
  • New ISO Standard Released for Characterizing Nanoparticles

    The International Standards Organization (ISO), an international body whose standards are often used by regulatory authorities, has unveiled new guidance on conducting toxicology tests on nanomaterials. ISO's 3 July 2012 technical report, "Nanotechnologies - Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment" (ISO/TR 13014:2012) is intended to be used to help researchers understand a nanomaterial's physicochemical ...
  • 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...
  • 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 ...