• 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...
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    FDA: Oximeters may be inaccurate in Black patients

    The US Food and Drug Administration (FDA) has issued a new safety communication about the limitations of using pulse oximeters to assess blood oxygen levels. The communication is based in part on findings that oximeters may yield falsely elevated readings in individuals with dark skin pigmentation, with the potential of masking dangerously low blood oxygen levels.   The agency’s communication comes in the context of the COVID-19 pandemic, which “has caused an increase ...
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    China’s new PAC regulation: Closer alignment with global best practices

    This article is a summarized translation of the most recent regulation published by China’s National Medical Products Administration (NMPA) on postapproval changes (PACs). The author provides an overview of the regulation and its annexes for PACs and discusses their impact on manufacturing site change management, change classification determination and consultation, and reporting categories.   Introduction On 13 January 2020, the NMPA published an announcement on t...
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    FDA calls for stakeholders to join MDUFA talks

    The US Food and Drug Administration (FDA) on Thursday called for non-industry stakeholders, including patient and consumer advocacy groups, to declare their interest in participating in consultation meetings for the next iteration of the Medical Device User Fee Amendments (MDUFA V) by 26 February 2021.   The monthly consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin next month. “FDA believes that consistent...
  • ReconRecon

    Recon: Kerfuffle over WHO's Wuhan mission; BMS inks $1.3 B cancer deal

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US New, Daily Coronavirus Cases Drop Below 100K For First Time In Months ( NPR ) U.S. Continues To Accelerate Vaccination Strategy ( NPR ) Seven coronavirus variants potentially similar to UK type have been detected in US: study ( The Hill ) ( NYT ) Fauci Awarded $1 Million Israeli Prize For 'Speaking Truth To Power' Amid Pandemic ( NPR ) Pentago...
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    European Commission explains management of legacy devices in Eudamed

    The European Commission this week posted a new document explaining how legacy devices and in vitro diagnostics (IVDs) will be managed in its Eudamed database.   After being delayed in 2019, Eudamed, a critical component of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched with the first of its six modules operational in December 2020. The remaining five modules are expected to roll out by the database’s May 2022 date of a...
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    For 2021, CDRH plans full ASCA pilot implementation

    A pilot conformity assessment program will be ready for full launch in 2021, according to a report by the US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH).   The report reviews the agency’s activities over the past year that supported full implementation of the Accreditation Scheme for Conformity Assessment (ASCA). Chief among these was the September 2020 publication of three final guidance documents that form the framework for ...
  • Feature ArticlesFeature Articles

    COVID-19 IVD test kits: Expedited response by Asian regulatory authorities

    After COVID-19 quickly spread from China to nearby Asian countries in early 2020, regulatory authorities in those neighboring countries adapted rapidly to introduce regulatory pathways for approval of in vitro diagnostic (IVD) test kits to facilitate widespread testing and halt spread of the disease. An additional challenge was that authorities had to work around strict quarantine restrictions, and applications and consultations had to be conducted online instead of in per...
  • ReconRecon

    Recon: Record-shattering 2020 healthcare investment; BIO layoffs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Who’s who in Biden’s health care team ( Medical Economics ) Biden begins presidency with aggressive healthcare agenda ( Healthcare IT News ) Biden Inherits a Vaccine Supply Unlikely to Grow Before April ( NYT ) Biden administration is trying to figure out what’s delaying Covid vaccine shots, CDC says ( CNBC ) How To Fix The Covid-19 Vaccine Rollout ( Forbes )...
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    FDA allows modifications to coagulation monitoring systems for COVID-19

    The US Food and Drug Administration (FDA) is allowing manufacturers to modify coagulation systems for measuring whole blood viscoelastic properties to allow for greater use in hospitals for the supportive management of patients with COVID-19.   The enforcement policy , which was issued in January 2021, is temporary and will remain in effort only for the duration of the COVID-19 public health emergency.   “As hypercoagulability has been observed in patients with CO...
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    European Commission appoints members to MDR/IVDR expert panels

    The European Commission this week released the names of members appointed to its 12 expert panels on medical devices and in vitro diagnostics (IVDs).   The expert panels, established under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will provide scientific, technical and clinical input to the Commission, its Medical Device Coordination Group (MDCG), member states, notified bodies and manufacturers. In particular, notified bodies ...