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    CDRH Talks Up Timeliness of NEST

    Members of the committee governing the National Evaluation System for health Technology Coordinating Center (NESTcc), including US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, touted the timeliness of NEST in a commentary in Clinical Pharmacology & Therapeutics on Tuesday. Shuren and NESTcc executive director Rachel Fleurence explain how the time for NEST has now come as certain “characteristics of medical ...
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    New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

    With a little more than a week left before the UK could depart from the EU without a deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday and Tuesday released 16 new and updated guidance documents, mostly related to marketing authorizations, variations and licensing. A couple of the guidance documents deal with how MHRA will authorize new medicines in the event of a no-deal Brexit, including guidance on how the agency will handle centraliz...
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    FDA Warns Integra’s TEI Biosciences Over Contamination Issues

    A TEI Biosciences medical device facility drew an US Food and Drug Administration (FDA) warning letter earlier this month over failures to prevent bacterial contamination of certain manufacturing equipment and products. The warning letter, made public on Tuesday, cites four good manufacturing practice (GMP) violations for the manufacturer of collagen-based medical devices. The first three GMP violations cover a lack of procedures to control environmental conditions as w...
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    FDA Finalizes Two Guidances on HIV Drug Development

    The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents to support the development of antiretroviral drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients and to aid the development of systemic drugs for the prevention of HIV-1 infection. The guidance from FDA comes as the agency has approved 29 drugs to treat HIV infection. FDA Commissioner Scott Gottlieb said in a statement that the guidance...
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    Asia Regulatory Roundup: Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository   Singapore’s Health Sciences Authority (HSA) has apologized to blood donors after a vendor stored their information in a vulnerable database. HSA learned the database lacked adequate safeguards from a cybersecurity expert and does not think other unauthorized people accessed the information...
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    CDRH to Review Materials Used in Medical Devices

    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.   “Modernizing the regulatory framework pertaining to the FDA’s review of medical device materials requi...
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    Behind the Numbers: FDA Offers Budget Specifics, New Proposals

    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). The 384-page justification breaks down where all the newly requested funding is expected to go, with $3.8 billion slated for medical product safety and availability, which is an incr...
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    Industry Calls to Eliminate Tiers in FDA’s Premarket Cybersecurity Guidance

    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. The draft, released in October 2018 , created a two-tiered approach to determining cyber risk, with higher risk devices falling into Tier 1 while other devices would be of “Standard Cybersecurity Risk” or Tier 2. But in comments on t...
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    Early FDA Review Finds Increased Mortality for Some Treated With Paclitaxel-Coated Devices

    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. “Of the three trials with 5-year follow-up data, each showed higher mortality in subjects treated with pacl...
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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    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. Last updated on 18 March 2019 to include: Biohaven Pharmaceutical Holding Company has purchased...
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    CDRH Program Seeks to Resolve 510(k) Issues in New Way

    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. “CDRH is implementing the least burdensome flag as a program for 510(k) submissions to act as a performance metric for the implementation of least burdensome requirements,” said Joshua Silverstein, regulatory advisory at CDRH’s Office of Device Evaluation (ODE...
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    EC Details Plan for Eudamed and Medical Device Nomenclature System

    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. The new documents comply with requirements that the 2017 regulations imposed on the Commission as part of the transitional periods to enter MDR and IVDR into force by 26 May...