• Regulatory NewsRegulatory News

    GAO: COVID-19 vaccine production falls short of January 2021 goal

    The Operation Warp Speed (OWS) goal to produce 300 million COVID-19 vaccine doses by January 2021 was not met, according to a status report released by the US Government Accountability Office (GAO).   Companies with current emergency use authorizations (EUAs) for vaccines are contracted under the program to release a combined 200 million doses of their vaccines by the end of March 2021 but had released just 63.7 million doses (31.8%) as of 31 January 2021, the report n...
  • EMA plans guidance on adapting vaccines for COVID variants

    The European Medicines Agency (EMA) on Wednesday said it will soon issue guidance explaining its expectations for adapting existing COVID-19 vaccines to protect against new and future variants of the virus.   The announcement comes just a week after the US Food and Drug Administration (FDA) said it is working on its own guidance to address these and other new variants of the virus. (Woodcock: FDA plans guidance to address new COVID-19 variants , Regulatory Focus 5...
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    January’s Regulatory Focus: The impact of disruption on the global regulatory community

    Feature articles during January focused the effects of disruption on global regulatory practice. In context of the COVID-19 pandemic, authors examined expedited approval pathways for test kits in southeast Asian countries; the role of digital promotional strategies in minimizing the impact of the pandemic on advertising, promotion, and labeling; and the importance of continuing soft-skills training during remote working. Under the broader framework of disruption, a group o...
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    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...
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    Impact of the COVID-19 pandemic on aspects of regulatory advertising and promotion

    This article discusses the impact of the COVID-19 pandemic on aspects of regulatory advertising and promotion. The author discusses how the shift from print to digital promotional strategies has affected certain elements of the regulatory review process and highlights considerations for carrying these learnings forward after the pandemic.   Introduction Almost a year out from the onset of the pandemic, COVID-19 continues to present challenges for regulatory adverti...
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    Building bridges through communication: Lessons learned in 2020

    The global pandemic has created many challenges this year for regulatory professionals, especially in the way it has transformed workplace interaction and communication. This article provides some helpful tips on video conferencing, phone calls, active listening, and trending business applications as a way of sharpening communication skills and improving business and regulatory interactions.   Introduction Regulatory affairs (RA) can be structured differently across ...
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    EU authorizes Pfizer-BioNTech COVID vaccine

    The European Commission on Monday conditionally authorized Pfizer and BioNTech’s COVID-19 vaccine after receiving a recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use earlier in the day.   The fast-tracked decision shortened what is usually a two-month procedure to a matter of hours, spotlighting the dire need for a vaccine as much of Europe faces lockdowns and restrictions amid a winter resurgence of the virus. The c...
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    FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom

    With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday to deliberate the standards the agency has set for authorization or licensure of a vaccine.   In a nine-hour public meeting meant to provide transparency and build public confidence in the process surrounding COVID-19 vaccine d...
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    How to assess symptoms in COVID-19 trials: new FDA guidance

    Investigators should use a patient-reported outcomes approach, with an emphasis on electronic data collection, in their research on therapies to treat or prevent COVID-19, according to a new guidance from the US Food and Drug Administration (FDA). The guidance, which is effective immediately during the public health emergency of the coronavirus pandemic, outlines how to capture disease-related symptoms in clinical trials focusing on COVID-19 prevention or treatment for ...
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    Regulatory Focus, August issue: Global clinical trials, clinical trial applications

    Feature articles during August focused on global clinical trials and clinical trial applications, with articles on regulatory options for conducting clinical trials in China, a case study on the impact of COVID-19 on submissions to European authorities, and an examination of Canada’s application process and alternate pathway for COVID-19‒related trials. Also included was an article on US Food and Drug Administration (FDA) updates on requirement for EUAs for diagnostics sup...
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    FDA requirement updates for EUAs for diagnostics to support COVID-19 pandemic

    This article discusses the evolution and implementation of the emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for diagnostic devices during the COVID-19 pandemic in the United States. The author suggests that this limited oversight will affect future requirements for demonstrable superiority claims after the EUAs are terminated and diagnostics for the virus undergo increased scrutiny by the agency for marketing authorization. She covers the ...
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    Interacting with competent authorities during COVID-19 – A European perspective

    This article covers direct interaction with various European authorities in regard to initial and amendment submissions and notifications related to urgent safety measures in response to the COVID-19 pandemic. The authors contacted selected European authorities to solicit data on submission events during 1 March and 30 June 2020. They found that the first 6-12 weeks of the pandemic presented challenges to numerous stakeholders but, after adjustments, the number of trials s...