• ReconRecon

    Recon: Novartis to Buy Endocyte for $2.1B

    • 18 October 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
  • Regulatory NewsRegulatory News

    FDA Looks to Harmonize Generic Drug Scientific and Technical Standards via ICH

    • 18 October 2018
    The US Food and Drug Administration (FDA) revealed Thursday that it’s offering a proposal to the International Council on Harmonisation (ICH) to better harmonize scientific and technical standards for generic drugs.
     
  • RAPS' LatestRAPS' Latest

    Making the Switch to Advertising and Promotion: My First 90 Days

    • 18 October 2018
    After more than three decades of working directly with the development, approval or clearance and subsequent commercialization of medical technologies, Steve Jwanouskos made the switch to advertising and promotion regulatory review. He found he was able to make the transition more smoothly and effectively by following a few simple steps in his first 90 days on the job.
  • Regulatory NewsRegulatory News

    Democrats Grill Drugmakers Over Tax Savings

    • 17 October 2018
    In letters to the CEOs of five top US drugmakers, 16 House Democrats question the companies’ actions on pricing, investment in research and development, employment, stock buybacks and executive compensation in light of tax savings as a result of the 2017 Tax Cuts and Jobs Act (TCJA).
  • Regulatory NewsRegulatory News

    EU Releases Working Plan to Implement MDR/IVDR

    • 17 October 2018

    The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations (MDR and IVDR).

  • Regulatory NewsRegulatory News

    Cybersecurity: FDA Spells Out Updated Premarket Policies

    • 17 October 2018
    With its first guidance in the device space in FY 2019, the US Food and Drug Administration (FDA) unveiled an awaited draft guidance on Wednesday to clarify the agency’s cybersecurity expectations from a premarket perspective.
  • Regulatory NewsRegulatory News

    CDRH Finalizes Classifications on Herpes Virus IVD, Limb Tremor Stimulator

    • 17 October 2018
    In final orders issued Tuesday, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) classified two new device types into class II (special controls).

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