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  • Regulatory NewsRegulatory News

    CONSORT-AI sets standards for reporting on artificial intelligence in trials

    A new consensus statement, dubbed the CONSORT-AI extension, lays out the rules of the road for clinical trial reports on interventions involving artificial intelligence (AI).   The statement, which was published in Nature Medicine and written by an international working group, includes 14 new items for researchers to routinely include in their manuscripts when reporting on AI interventions.   The statement calls on researchers who report on trials that include AI...
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    Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance

    Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel coronavirus pandemic, according to an updated guidance from the US Food and Drug Administration (FDA).    The updated information came on 21 September 2020 in the form of a new addition to the questions and answers in the FDA's guidance on conduct of clinical trials of medical pro...
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    FDA calls for stakeholders to join GDUFA talks

    The US Food and Drug Administration (FDA) this week called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Generic Drug User Fee Amendments (GDUFA III) program.   The call comes less than two months after the agency held its GDUFA III reauthorization kickoff meeting, during which industry stakeholders sought improvements to the generic...
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    EMA finalizes pediatric trial preparedness framework

    The European Medicines Agency (EMA) has released the final version of a framework for pediatric clinical trial preparedness. The final document aims to “increase the likelihood of a smooth and timely course of a paediatric clinical trial, integrating information from multiple stakeholders on what is possible within individual studies and therefore also for the overall drug development plan within which a trial is embedded,” according to EMA.   This framework’s releas...
  • Feature ArticlesFeature Articles

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

    This article discusses recent changes to clinical trial regulation in China. The author suggests that Chinese clinical trials for medical devices and in vitro diagnostic device (IVD) products are an increasingly viable option for non-Chinese companies of all sizes.   Introduction: China’s regulatory framework Most life sciences products sold in China, including medical devices and IVDs, are supervised by the National Medical Products Administration (NMPA), formerly k...
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    Canada extends non-COVID clinical trial review times

    Health Canada will have an additional 15 days to review clinical trial applications for drugs that are unrelated to the coronavirus disease (COVID-19) pandemic through 16 November, after Canada’s Minister of Health Patricia Hajdu ordered the extension last week.   Normally, Health Canada has 30 days to review clinical trial applications and amendments for drugs submitted under Division 5 of the country’s Food and Drug Regulations . If the agency does not object to a...
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    Draft AML guidance takes targeted therapies into account

    The US Food and Drug Administration(FDA)  has issued a new draft guidance for developers of drugs and biologics to treat acute myeloid leukemia (AML).   The new draft guidance takes into account a shift in the treatment landscape for AML as new targeted treatments are being developed for this and other cancers. "In some cases, these newer approaches may extend survival without the prospect for cure, but extending survival may be a meaningful benefit for patients who wo...
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    FDA updates bioresearch monitoring e-submission guide

    A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US Food and Drug Administration.   The guide provides detailed information for electronic submission of clinical trial data (e-CTD) by sponsors in advance of submissions for new drug applications, biologics license applications, and supplemental submissions. The technical specifications document delineates details of the electronic submissions framework la...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    The Canadian application process and alternate pathway for COVID-19‒related clinical trials

    This article offers an overview of the clinical trial application process and guidance on the regulatory obligations pursuant to Part C, Division 5, of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” in Canada. The authors focus on clinical trial applications only for biologics (schedule D) and pharmaceuticals (schedule F). They provide information on a range clinical trial submission requirements and communication with Health Canada’s re...
  • Feature ArticlesFeature Articles

    Managing uncertainty: Regulatory reporting in multinational trials during COVID-19

    This article discusses regulatory reporting challenges for multinational clinical trials during the COVID-19 pandemic. The author covers the pandemic’s impact on clinical research, national guidelines, and harmonization, as well as the challenge of assessing what is reportable and how to submit COVID-19 risk mitigation measures. She offers real-world experience on how she and her colleagues stopped and restarted recruitment in ongoing multinational clinical trials, and how...