• Regulatory NewsRegulatory News

    CDRH Draft Guidance Tackles Nitinol Devices

    • 18 April 2019
    As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed technical considerations for nitinol-containing devices.
     
  • Regulatory NewsRegulatory News

    Australia and Canada Jointly Approve Breast Cancer Drug

    • 18 April 2019
    As part of a push toward regulatory convergence, Health Canada and Australia’s Therapeutic Goods Administration (TGA) last week jointly approved Eli Lilly’s Verzenio (abemaciclib) for the treatment of metastatic breast cancer.
     
  • Regulatory NewsRegulatory News

    CDRH Drafts Guidance on Quantitative Imaging

    • 18 April 2019
    Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday.
     

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