• Regulatory NewsRegulatory News

    CDRH, MDIC Look to Global Application for NEST

    • 24 September 2018
    With the first version of the National Evaluation System for health Technology (NEST) set to open for business by the end of 2019, the shared vision among management at the US Food and Drug Administration (FDA) has expanded to a global scope.
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Benefit-Risk Factors for 510(k)s

    • 24 September 2018
    The US Food and Drug Administration (FDA) on Monday finalized guidance on evaluating the benefit-risk profile of medical devices submitted under the 510(k) pathway that have the same indication as their predicate devices but have different technological characteristics and benefit-risk profiles.
  • Regulatory NewsRegulatory News

    Phase 3 Trial Costs Estimated at $19M, Study Finds

    • 24 September 2018
    The cost of a Phase III clinical trial ranges widely, though a new study pegs the median cost of 138 clinical trials in 2015 and 2016 at $19 million.
  • Regulatory NewsRegulatory News

    Researchers Point to R&D Treaty to Spur New Infectious Disease Treatments

    • 24 September 2018
    As current incentives to promote the development of new infectious disease treatments have yet to reach their potential, researchers in a new Food and Drug Law Journal paper suggest forming a research and development treaty.
     
  • Regulatory NewsRegulatory News

    Brexit-Related Medicine Supply Disruptions: EMA Revises List

    • 24 September 2018
    The European Medicines Agency (EMA) on Monday announced that the number of centrally authorized medicines (CAPs) for which there are Brexit-related supply disruption concerns has declined from 108 to 39 (25 human medicines and 14 veterinary medicines).
     
  • Regulatory NewsRegulatory News

    EMA Extends Valsartan Review to Include Four More Active Substances

    • 21 September 2018
    The European Medicines Agency (EMA) announced Friday it has extended its review of two impurities classified as probable human carcinogens from its initial valsartan focus to include medicines containing four other “sartans.”
  • Regulatory NewsRegulatory News

    DITTA Calls on FDA, Health Canada to Take Up Proposed IMDRF Work on Cybersecurity

    • 21 September 2018
    A new work item on cybersecurity was proposed at the International Medical Device Regulators Forum (IMDRF) management committee hearing this week in Beijing, China by the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA).
  • Regulatory NewsRegulatory News

    CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys

    • 21 September 2018
    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended thirteen new medicines for EU approval and reaffirmed its negative opinion of Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys (eteplirsen).

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