• Regulatory NewsRegulatory News

    Former FDA Commissioners Make the Case for an Independent Regulatory Agency

    • 19 October 2018

    At a plenary session at the American University in Washington, DC four former US Food and Drug Administration (FDA) commissioners argued for FDA to be an independent regulatory agency.

  • Regulatory NewsRegulatory News

    FDA Tweaks List of Recognized Consensus Standards for Devices

    • 19 October 2018
    A total of about 90 consensus standards used for device premarket reviews and other device regulatory requirements will undergo certain modifications set forth Friday in a notice from the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
  • Regulatory NewsRegulatory News

    Health Canada Puts Brakes on SaMD Draft Guidance

    • 19 October 2018
    A scientific advisory panel on software as a medical device (SaMD) convened in January by Health Canada caused the agency to hit the brakes on a draft guidance document.
     
  • Regulatory NewsRegulatory News

    EMA’s CHMP Recommends Six Medicines for Approval

    • 19 October 2018
    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced the recommendation of six medicines for approval, including two orphan medicines, as well as three extensions of indications and a new vice-chair.
     
  • Regulatory NewsRegulatory News

    CDRH Issues Final Orders on 6 Medical Device Classifications

    • 18 October 2018
    A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.
     
  • Regulatory NewsRegulatory News

    Manufacturers Not Ready for November DSCSA Deadline, Study Finds

    • 18 October 2018
    A new study found that pharmaceutical manufacturers are woefully behind in meeting a 27 November deadline, as nearly 80% of pharmaceutical packages still do not have a readable barcode with all four required data elements necessary to meet the requirements of the Drug Supply Chain Security Act (DSCSA).
     
  • Regulatory NewsRegulatory News

    EMA Announces Pharmacovigilance Fee Increase

    • 18 October 2018
    Pharmacovigilance fees payable to the European Medicines Agency (EMA) were increased by 1.7% on Thursday to account for inflation in 2017.
  • 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).

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