• 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...
  • As Biosimilar Problems Emerge, EMA Looks to Create Quality Comparability Guideline

    The European Medicines Agency (EMA) has released a new concept paper calling for the development of a new framework to help solve one of the most difficult challenges associated with the development of biosimilar and biological products: ensuring that the quality of the biological product meets intended standards at all times during the development process. The concept paper , released on 28 June 2013, explains that EMA has received several requests in recent years rega...
  • 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...
  • EMA Looks to Build Framework to Allow for Less Burdensome Clinical Testing

    The European Medicines Agency (EMA) has announced the release of a new concept paper regarding the extrapolation of an experimental drug product's safety and efficacy data to other subgroups, explaining that a new guideline is needed to instruct industry on how to validate their conclusions. Background Regulators processes are an inherent balancing act between two competing forces: The need to get new therapies to patients and the need to make sure said therapies are sa...
  • 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...
  • FDA Releases Draft Guidance on Design of Home Use Medical Devices

    The US Food and Drug Administration (FDA) has released a new medical device draft guidance intended to assist manufacturers in designing and developing devices used by a patient in their own home-so-called "home use" devices. The devices covered include infusion pumps, cold packs, oxygen supplies, CPAP machines, wheelchairs, walkers and more. As defined by FDA, they are any device capable of being used outside of a professional healthcare facility or clinical laboratory....
  • 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...
  • Revisions to Osteoporosis Guideline Called for by EMA

    The European Medicines Agency (EMA) has released a new concept paper calling for revisions to the way osteoporosis products are evaluated in the EU, saying existing guidelines are largely inadequate to assess a secondary form of the disease. The problem, explained EMA, is that current osteoporosis guidelines only cover primary osteoporosis, and do not address the evaluation of products used to treat secondary osteoporosis, often brought on by glucocorticoid therapy. Gl...
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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...