• Regulatory NewsRegulatory News

    FDA nixes GUDID submission requirements for class I consumer healthcare devices

    Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the US Food and Drug Administration’s (FDA) Global Unique Device Identification Database (GUDID) submission requirements under a draft guidance issued on Wednesday.   Under the agency's unique device identification (UDI) compliance policy guidance issued in June 2020, class I devices, other than implantable, life-supporting, and life-sustaini...
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    Unanimous thumbs up from FDA committee for Moderna booster

    An advisory committee to the US Food and Drug Administration (FDA) voted unanimously to recommend a half-strength booster dose of the mRNA COVID-19 developed by Moderna and the National Institutes of Health for those 65 years and older, and for certain younger populations at high risk of severe COVID-19.   Moderna has requested an emergency use authorization (EUA) for the 50 mcg booster dose for individuals who have already completed the two-dose series of the Moderna ...
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    IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage

    Amid concerns of a market collapse and a "grave shortage" of notified body capacity, the European Commission on Thursday proposed to delay the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR).   The medical device industry has long pushed for the EU to delay IVDR, warning that the new regulation is more disruptive to the market for diagnostics than its counterpart Medical Devices Regulation (MDR), which itself was delay...
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    Euro Roundup: EMA warns action against titanium dioxide will cause significant drug shortages

    The European Medicines Agency (EMA) has found that requiring manufacturers to replace titanium dioxide (TiO2) in medicines “will almost certainly cause significant medicines shortages and discontinuations/withdrawals ... with major implications for patients and animals.”   EMA investigated the impact of phasing out the use of the excipient at the request of the European Commission. The Commission’s request was triggered by a European Food Safety Authority (EFSA) recomm...
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    Recon: White House reportedly eyeing Califf as FDA commissioner; EU kicks off review of AstraZeneca COVID antibody cocktail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House zeroes in on Califf to head FDA as deadline nears ( Washington Post ) U.S. FDA advisers weigh case for COVID-19 vaccine booster shots ( Reuters ) ( STAT ) J&J COVID-19 shot gets better boost from Moderna or Pfizer in NIH study ( Reuters ) ( NBC ) Data from Federal Scientists Raise Questions About J.&J. Booster Shots ( NYTimes ) Biden official warn...
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    IT and staffing issues impeded CDRH pandemic test response: Report

    Lagging information technology infrastructure, inefficient staffing, and validation methods that were not set up for a pandemic were among the weaknesses identified by an outside assessment of the U.S. Food and Drug Administration’s (FDA's) handling of COVID-19 diagnostic test emergency use authorizations (EUAs) during the pandemic.   The independent report, conducted by the consulting firm Booz Allen Hamilton at the request of FDA's Center for Devices and Radiological...
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    FDA Approvals Roundup: Tavneos, Verzenio, Dextenza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tavneos okayed for ANCA-associated vasculitis ChemoCentryx’s Tavneos (avacopan) has been approved as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, also known as ANCA-associated vasculitis, in combination with standard therapy.   ANCA-associated vasculitis is a group of thr...
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    FDA warns companies for GMP violations, conducting trial without IND

    A contact testing laboratory found in violation of Current Good Manufacturing Practice (CGMP) regulations and a nutritional supplement company conducting a clinical investigation without an investigational new drug application (IND) have been sent warning letters by the US Food and Drug Administration (FDA).   FDA sent Missouri Analytical Laboratories Inc. a warning letter on 30 September due to “significant violations” of CGMP and “significant deviations from CGMP" fo...
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    Recon: FDA approves Lilly's Verzenio for early breast cancer; Ebola vaccination campaign begins in Congo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Data suggests mRNA booster dose generates stronger antibody response after J&J shot – Axios ( Reuters ) Relying on J&J's analyses to assess vaccine booster dose data -U.S. FDA staff ( Reuters ) ( NYTimes ) US FDA staff says Moderna did not meet all criteria for COVID-19 boosters ( Reuters ) Vaccine requirements raised COVID-19 vaccination rates by 20 percentag...
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    ICMRA: Industry's commitment to quality can facilitate regulatory flexibility

    Frequent communication with industry and relying on assessments by other regulators have enabled the rapid scale-up of COVID-19 vaccines and therapeutics, asserted regulators and industry representatives attending a July workshop sponsored by the International Coalition of Medicines Regulatory Authorities (ICMRA).   The workshop explored how different regulatory tools are being deployed to increase manufacturing capacity for vaccines during the COVID-19 pandemic. The...
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    Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

    TGA releases guide to classifying active medical devices by risk   New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.   The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU w...
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    EMA's challenges through 2023: Global collaboration, supply shortages, antimicrobial resistance

    The European Medicines Agency (EMA) recently released its final programming document for 2021 to 2023, setting goals to address medicine availability and shortages, analysis and access to healthcare data, supply chain issues, and antimicrobial resistance.   Emer Cooke, EMA Executive Director, stated in the document’s foreword that much of the agency’s planning over the next few years will be accomplished by implementing the EMA Network Strategy and Regulatory Science S...