• Regulatory NewsRegulatory News

    NESTcc Unveils 2019 Operational Plan to Serve as ‘Front Door to Conduct RWE Studies’

    • 18 January 2019
    The center charged with coordinating the development of the National Evaluation System for health Technology (NEST) released a long-awaited “strategic and operational plan for 2019” on Friday.
     
  • 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).
  • Feature ArticlesFeature Articles

    The Changing Landscape of Drug Promotion in a Digital World and What it Means for Regulatory Reviewers

    • 18 January 2019
    This article discusses the changing landscape of drug promotion and what relevant technological communication changes, such as the Internet and social media, may mean for regulatory reviewers
  • RAPS' LatestRAPS' Latest

    RAPS 2019 Board of Directors Begins Term; Don Boyer Takes Helm as Chair

    • 18 January 2019
    RAPS welcomed its 2019 board of directors, which officially began its term on 1 January. Don Boyer, a former top Health Canada official who is now a private regulatory consultant, takes over as chairman.
  • Regulatory NewsRegulatory News

    FDA Modifies REMS Program for Clozapine

    • 17 January 2019
    The US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.
  • Regulatory NewsRegulatory News

    Mail Order Pharmacies Can Lessen Generic Usage, Study Finds

    • 17 January 2019
    Although nearly 90% of all drugs dispensed in the US are now generic drugs, a new study published in Therapeutic Innovation & Regulatory Science explores the determinants of generic substitution across therapeutic classes and found that in five of eight studied classes, patients using a mail order pharmacy had significantly less generic substitution than patients filling at retail pharmacies.
     

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