• 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).
  • Regulatory NewsRegulatory News

    FTC Charges First Marketer of Intravenous Products

    • 21 September 2018
    The Federal Trade Commission (FTC) has, for the first time, charged a marketer and seller of intravenously injected therapy products, known as iV Cocktails, with making a range of “deceptive and unsupported health claims” about their ability to treat serious diseases.
     

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