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  • New Device Standards Released, Including Many on Cybersecurity

    The US Food and Drug Administration (FDA) has released two new lists of updated medical devices standards recognized by FDA for the purposes of meeting current good manufacturing practices (CGMPs) and other review requirements. The two lists, Modifications to the List of Recognized Standards, Recognition List Number: 031 and 032 "will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices," FDA e...
  • FDA Announces Major Funding for WHO to Support Regulatory Capacity, Harmonization

    US regulators have announced a five-year, multimillion-dollar contract with the World Health Organization (WHO) intended to support regulatory science and enhance global regulatory capacity through improved harmonization and the development of standards. The Office of International Programs The funding opportunity is made available through FDA's Office of International Programs (OIP), now headed by John Taylor, acting deputy commissioner, and Mary Lou Valdez, associat...
  • US Throws Out 1995 Standard for Generics Stability Testing, Adopts ICH Standards for NDAs Instead

    The US Food and Drug Administration (FDA) has released a new guidance for industry that pertains to stability testing recommendations for generic drug products submitted under 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) as an abbreviated new drug application (ANDA) or a drug master file (DMF). The June 2013 guidance document, ANDAs: Stability Testing of Drug Substances and Products , explains that, "Over the past few years, the Office of Gener...
  • China Recognizes Device Electromagnetic Testing Centers

    In December 2012, China's State Food and Drug Administration's (SFDA) National Medical Standardization Technical Committee issued a standard (YY 0505-2012) that is equivalent to the international electromagnetic compatibility testing standard (IEC 60601-1-2), with an effective date of 1 January 2014. To date, the SFDA says it has recognized a number of medical device testing institutions that are qualified to carry out the detection of electromagnetic compatibility of...
  • Dozens of Medical Device Standards Adopted, Re-Affirmed by FDA

    The US Food and Drug Administration (FDA) has released a new Federal Register notice indicating the modification of 116 medical device standards recognized by the agency, as well as 38 new device standards now recognized. The oft-updated List of Recognized Standards is generally updated anywhere between one and three times per year, and was last updated in August 2012 and before that in March 2012. It was created under the FDA Modernization Act of 1997, which gav...
  • PCORI Board Adopts CER Standards

    The Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI) at its 19 November 2012 meeting in Boston, MA adopted 47  revised methodology standards  that are intended to guide the comparative effectiveness research (CER) funded by PCORI.  The Board also authorized at the meeting the development of three new CER funding announcements: Treatment options for uterine fibroids, the safety and benefits of treatment options for severe asthm...
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    Regulators, Industry Discuss Potential Impact of IMDRF

    The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body, but you wouldn't know it by looking at its membership or its ambitions. The organization, launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), sports an impressive array of members for an organization in its infancy: the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's Nationa...
  • Groups, FDA Announce Launch of New Clinical Data Standards Harmonization Partnership

    The US Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) have announced the formal launch of a new clinical data standards consortium known as the Coalition for Accelerating Standards and Therapies (C-FAST). Both CDISC and C-Path are data organizations which set many of the global standards used to report data from clinical trials. The partnership between all three organizations w...
  • Consortium Brings Together FDA, Industry to Release New Data Reporting Standard

    Officials with the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path), two organizations strongly affiliated with the US Food and Drug Administration (FDA), have announced the release of a new "breakthrough tool" used to help combine and report data from multiple studies. The new tool is set to be used to standardize the way companies report data from research on drug regimens intended to treat tuberculosis (TB), a bacterial...
  • FDA Approves 32 New Medical Device Standards

    The US Food and Drug Administration (FDA) has announced the adoption of a number of new international standards to guide the development and regulatory review of some medical devices. The standards, collected within FDA's List of Recognized Standards , are used by FDA during the premarket review of some products and allow a company or product to claim conformity to the standards to satisfy certain components of the review process. The FDA Amendments Act of 2007...
  • Legislation Would Subject FDA Information Inquiries to Performance Standards

    Under a new piece of bipartisan legislation introduced in the Senate, all federal agencies, including the US Food and Drug Administration (FDA), would be subject to new standards intended establish performance measures and standards. The Government Customer Service Improvement Act of 2012 , sponsored by Sens. Mark Warner (D-VA) and Ron Johnson (R-WI), was introduced in the Senate on 31 July 2012. Under the proposed legislation, the Office of Management and Budget (...
  • 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 ...