• Regulatory NewsRegulatory News

    Shuren and Stenzel: Bending the arc of testing for COVID – and beyond

    The U.S. Food and Drug Administration’s efforts to rapidly authorize point-of-care and at-home tests during the COVID-19 pandemic could offer a roadmap for a broad effort to bring diagnostic and screening tests to homes and remote locations for a variety of diseases. “The development and authorization of COVID-19 [point-of-care] and at-home tests has been remarkable; a process that can often take more than a year took only a few months in many cases. We believe that les...
  • Regulatory NewsRegulatory News

    Device, digital health firms oppose HHS’ proposed 510(k) exemptions

    Medical device and digital health companies have largely come out in opposition to a proposal from the Department of Health and Human Services (HHS) to permanently exempt 84 types of medical devices from premarket notification (510(k) requirements.   The proposal was made in the final days of the Trump administration and was pushed through without consulting the US Food and Drug Administration (FDA), the agency that would typically issue such a notice. All the devices ...
  • ReconRecon

    Recon: uBiome founders garner $60m SEC fraud charge; Idera's melanoma drug flops Ph 3

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies ( Pink Sheet ) Experts Warn U.S. Could See New Coronavirus Hot Spots ( NPR ) Biden says 65% of people 65 or older have received at least one COVID vaccine shot ( Reuters ) Drugmakers brace for a pricing fight as Xavier Becerra is confirmed as the next HHS secretary ( Endpoints ) New HH...
  • Regulatory NewsRegulatory News

    FDA offers real-world evidence examples in device applications

     The US Food and Drug Administration (FDA) is offering a detailed look at how real-world evidence sources – from registries to claims data – can be used to support marketing applications for medical devices.   A new report from the FDA’s Center for Devices and Radiological Health (CDRH) breaks down 90 examples in which real-world evidence was used to support final premarket or postmarket regulatory decisions from Fiscal Year 2012 through 2019. These examples include ...
  • Regulatory NewsRegulatory News

    Updated: FDA smooths the path for COVID screening tests

    Editor’s note: This story has been updated to include remarks and perspective from an FDA Town Hall for test developers.   At the one-year mark of the public health emergency of the pandemic, the US Food and Drug Administration (FDA) is providing a smoother road to the authorization of COVID-19 tests to screen asymptomatic individuals.   On Tuesday, FDA issued a fact sheet for those who are interested in setting up screening programs, an update to its FAQ do...
  • MDCG releases rapid COVID antibody test guidance

    Europe’s Medical Device Coordination Group (MDCG) has set out guidance for developers of rapid COVID-19 antibody tests, identifying minimum performance criteria and considerations for devices intended to detect antibodies against SARS-CoV-2.   In formulating the guidance , MDCG looked to other regulators’ considerations for antibody tests, including the World Health Organization (WHO). Additionally, the working group reviewed the instructions for use from 102 separate...
  • Regulatory NewsRegulatory News

    MDCG addresses custom devices under MDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Monday issued a new questions and answers document addressing custom-made medical devices under the Medical Device Regulation (MDR) and providing considerations for adaptable and patient-matched devices.   Custom-made devices (CMDs) are defined under MDR as devices made specifically in accordance with a written prescription by an authorized person that have specific design characteristics and are i...
  • RF Quarterly

    RF Quarterly, March 2021: Global clinical trials

    Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...
  • RF Quarterly

    Initiating clinical trials in China: What foreign medtech companies need to do

    This article discusses numerous recent changes in the regulation of clinical trials in China and proposes that Chinese clinical trials for medical device and in vitro diagnostic device (IVD) products are an increasingly viable option for non-Chinese companies of all sizes. [Updated]*   China’s regulatory framework Most life sciences products, including medical devices and IVDs, sold in China are supervised by the National Medical Products Administration (NMPA).  The ...
  • ReconRecon

    Recon: 2021's priciest drugs; A leaderless FDA?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis' canakinumab failed to improve survival in Phase III trial ( Reuters ) ( Endpoints ) Is a leaderless FDA clamping down on drug reviews? Not knowing is weighing heavy on biotech ( STAT ) Pandemic Forces FDA to Sharply Curtail Drug Company Inspections ( NYT ) A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Admini...
  • Regulatory NewsRegulatory News

    Global medicinal supply chain examined in EC, US efforts

    The European Commission has launched a structured dialog addressing pharmaceutical supply chain initiatives, aiming to safeguard the security of the European Union’s supply of medicines. A 26 February launch meeting kicked off the structured dialog initiative, which brings together national authorities, patients, nongovernmental organizations working in the health sector and members of the research community.   By coming to a clearer understanding of how global medical...
  • Feature ArticlesFeature Articles

    February's Regulatory Focus: Global and regional harmonization and alignment

    Feature articles during February included a range of topics focused on harmonization and alignment across global and regional regulatory entities, including electronic submissions through the European Medicines Agency (EMA), tools for updating the EU In Vitro Diagnostic Regulation (EU IVDR) template, China’s new PAC regulation, Project Orbis and improving patients access to new therapies, as well as a report on medtech companies’ preparation for EU Medical Device Regulatio...