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  • Regulatory NewsRegulatory News

    FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

    The US Food and Drug Administration (FDA) on Tuesday unveiled a new initiative whereby its Oncology Center of Excellence (OCE) will work to approve new cancer drugs alongside Australia’s Therapeutic Goods Administration (TGA) and Health Canada. The collaboration, dubbed Project Orbis , was launched with FDA’s decision with TGA and Health Canada to grant accelerated approval to Eisai's Lenvima (lenvatinib) in combination with Merck's Keytruda (pembrolizumab) for the tre...
  • Regulatory NewsRegulatory News

    As the Race for a Permanent FDA Commissioner Picks Up, Agency Turnover Continues

    With a decision on a permanent US Food and Drug Administration (FDA) Commissioner slated for the end of October at the latest, the steady stream of FDA employee defections to industry continues. So, who will be nominated as the next commissioner? Some influential health groups and former FDA commissioners (including Scott Gottlieb), according to the Washington Post , are pushing for Acting Commissioner Ned Sharpless to be nominated, while the Wall Street Journal...
  • Regulatory NewsRegulatory News

    Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger

    Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA). This has been the story at FDA from FY 2016 to FY 2017 to FY 2018 and now to FY 2019 , with two months to spare. But questions remain on whether these approvals are actually translating into greater competition and lower costs for patients. A report from Pew earlier this year found that the increase in approved generic drugs fr...
  • Regulatory NewsRegulatory News

    NCI’s Sharpless to Serve as Acting FDA Commissioner

    The US Department of Health and Human Services (HHS) announced Tuesday that Dr. Ned Sharpless, current director of the National Cancer Institute (NCI) at the National Institutes of Health, will serve as acting US Food and Drug Administration (FDA) commissioner when Scott Gottlieb steps down next month. Sharpless, who has served as NCI director since October 2017, previously served as director of the University of North Carolina (UNC) Lineberger Comprehensive Cancer Cent...