• Regulatory NewsRegulatory News

    CDRH to Review Materials Used in Medical Devices

    • 18 March 2019
    Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren on Friday announced plans to improve the agency’s approach to evaluating material safety and biocompatibility.
  • Regulatory NewsRegulatory News

    Behind the Numbers: FDA Offers Budget Specifics, New Proposals

    • 18 March 2019
    Further modernizing generic drug and new drug reviews and development, improving medical device safety and additional efforts to support the opioid crisis will all see additional funding next year, according to the FY 2020 budget justification from the US Food and Drug Administration (FDA).
     
  • Regulatory NewsRegulatory News

    Industry Calls to Eliminate Tiers in FDA’s Premarket Cybersecurity Guidance

    • 18 March 2019
    GE Healthcare, the Medical Imaging and Technology Alliance (MITA), Becton, Dickinson and Company (BD) and industry group AdvaMed are all seeking tweaks to draft guidance on managing cybersecurity in medical device premarket submissions.
  • ReconRecon

    Recon: Apple Watch Identifies Irregular Heart Beat in Large Study

    • 18 March 2019
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
  • Regulatory NewsRegulatory News

    Early FDA Review Finds Increased Mortality for Some Treated With Paclitaxel-Coated Devices

    • 18 March 2019
    The US Food and Drug Administration (FDA) said Friday that a preliminary review of long-term follow-up data has identified a “potentially concerning signal of increased long-term mortality” in study subjects treated for peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents when compared to patients treated with uncoated devices.
     
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    • 18 March 2019
    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.
  • Regulatory NewsRegulatory News

    CDRH Program Seeks to Resolve 510(k) Issues in New Way

    • 15 March 2019
    A quietly-launched pilot at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) was implemented last Monday to evaluate a new approach to resolving issues in 510(k) submissions.
     
  • Regulatory NewsRegulatory News

    EC Details Plan for Eudamed and Medical Device Nomenclature System

    • 15 March 2019
    The European Commission (EC) issued long-awaited documents on two essential actions to implement the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR), namely the high-level functional specifications for Eudamed and its final assessment on the future nomenclature for the database.
     
  • Regulatory NewsRegulatory News

    EMA Begins Review of Screening Patients Before Fluorouracil

    • 15 March 2019
    The European Medicines Agency (EMA) on Friday initiated a review of existing screening methods and their value in identifying patients at increased risk of severe side effects when taking medicines containing fluorouracil (also known as 5-fluorouracil or 5-FU) and the related medicines capecitabine, tegafur and flucytosine, which are converted to fluorouracil in the body.
     
  • Regulatory NewsRegulatory News

    CDER Looks Ahead at Real World Evidence

    • 15 March 2019
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Friday held a webinar reviewing the agency’s real-world evidence (RWE) framework, which deals primarily in the postmarket space for drugs and biologics.
  • Regulatory NewsRegulatory News

    Harvard to Offer Free Online Course on Pharma Controversies

    • 15 March 2019
    Beginning 26 March, three instructors at Harvard Medical School will begin offering a new free online course on controversial topics related to the US Food and Drug Administration (FDA), drug prices, off-label marketing and other programs like the priority review voucher and Orphan Drug Act.
     

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