• Regulatory NewsRegulatory News

    FDA Launches Probe into Drug-containing Balloons, Stents

    • 18 January 2019
    Paclitaxel-coated balloons and paclitaxel-eluting stents prompted a US Food and Drug Administration (FDA) letter to health care providers after a 2018 meta-analysis suggested an increased mortality rate in patients that received peripheral arterial disease (PAD) treatment with either of the device types.
     
  • Regulatory NewsRegulatory News

    FDA Approves 17th Biosimilar, Third for Herceptin

    • 18 January 2019
    The US Food and Drug Administration (FDA) on Friday approved Merck and Samsung Bioepis’ Ontruzant (trastuzumab-dttb), the third biosimilar approved in the US to Roche’s Herceptin (trastuzumab).
     
  • Regulatory NewsRegulatory News

    Industry Calls for Metrics on CDRH’s Breakthrough Device Program

    • 18 January 2019
    A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority review program run by FDA’s Center for Devices and Radiological Health (CDRH).

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