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  • Regulatory NewsRegulatory News

    Experts urge transparency, advisory committee review for COVID-19 vaccines

    At a virtual briefing on Tuesday, several experts told members of the House Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy that a transparent process and advisory committee review will be key to the effective rollout of a vaccine to prevent coronavirus disease (COVID-19).   The briefing comes just two weeks after the US Food and Drug Administration (FDA) issued guidance on the development and licensure of vaccines against SARS-CoV-2, the...
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    FDA updates COVID-19 therapeutics website

    The US Food and Drug Administration (FDA) has to date reviewed over 230 trials of potential therapeutics to treat the novel coronavirus (COVID-19), according to a blog post by FDA commissioner Stephen Hahn, MD and colleagues. Over 510 COVID-19-directed drug development programs have reached the planning stage.   In the blog, agency officials provide an update on FDA’s Coronavirus Treatment Acceleration Program (CTAP), a set of resources designed to allow cross-agency...
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    FDA looks to resume domestic inspections this month

    Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Friday said it plans to resume on-site domestic inspections beginning the week of 20 July 2020.   As a safety measure, FDA will pre-announce all inspections, save for retail tobacco inspections, for the foreseeable future.   The announcement comes nearly two months after the agency said it will implement a phased approach to restartin...
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    Marks on COVID-19 vaccine efficacy, EUAs and challenge trials

    A week after the US Food and Drug Administration (FDA) issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and Research, shed light on the reasoning behind the agency’s 50% efficacy threshold and where the agency stands on challenge trials and emergency use authorizations (EUAs).   Efficacy and approval   In its guidance, FDA said it expected sponsors to demonstrate a vaccine is at leas...
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    ICMRA outlines shape of Phase 3 COVID-19 vaccine trials

    A new report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2, the virus that causes COVID-19. The report indicates which clinical and preclinical data will indicate a vaccine is ready for Phase 3 trials; it also lays out key considerations in designing Phase 3 clinical trials of vaccines for COVID-19.   The report reflects consensus reached at a 22 June 2020 teleconference convened by the US Foo...
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    NIH kicks off COVID-19 vaccine, monoclonal antibody research network

    The National Institutes of Health (NIH) today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the virus that causes infection with the novel coronavirus COVID-19.   The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS.   “Star...
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    FDA clarifies informed consent provisions in COVID-19 clinical guidance

    The US Food and Drug Administration (FDA) last week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to clarify how sponsors can obtain informed consent from patients in isolation or who can receive electronic copies of informed consent documents but due to time constraints cannot print or electronically sign the documents.   The guidance , which has been updated frequently as more questions arise from sponsors during...
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    EU agencies clarify pharmacovigilance expectations amid COVID-19

    In an update to their joint questions and answers document on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, the European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies (HMA) expand on their expectations for pharmacovigilance.   The updated document features three new questions related to pharmacovigilance, covering topics from corrective and preventive actions management to pharmacovigila...
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    FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold

    In an immediately effective guidance issued Tuesday, the US Food and Drug Administration (FDA) sets its expectations for the development and licensure of vaccines to prevent coronavirus disease (COVID-19), including considerations for manufacturing, nonclinical and clinical studies and post-licensure requirements.   For a vaccine that would be widely deployed against COVID-19, FDA says it expects sponsors to demonstrate that the vaccine is at least 50% effective in a p...
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    WHO ACT-Accelerator prioritizes global vaccine approach

    The importance of a global approach to vaccine development and production, with a focus on collaboration, was a topic of a technical update and press briefing held 26 June by the World Health Organization (WHO).   The usual practices for drug development have been upended by the speed and scale of the COVID-19 pandemic, said officials. “I’m very hopeful and optimistic that this will be an unprecedented collaboration that also sets a model for the future,” said WHO Chie...
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    EMA revises methodological guidance for trials impacted by COVID-19

    Following a four-week public consultation, the European Medicines Agency (EMA) on Monday revised its guidance on methodological considerations for ongoing clinical trials amid the coronavirus disease (COVID-19) pandemic.   The agency also says it will extend its decision to hold all upcoming committee and working party meetings virtually through September 2020. The agency adds that it will continue its practice of holding stakeholder events virtually or postponing th...
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    Revise remdesivir EUA to add registry, say researchers

    The US Food and Drug Administration (FDA) should create a patient registry to track key information about COVID-19 patients treated with remdesivir, according to three Harvard Medical School researchers. The researchers also called for FDA to begin negotiations with Gilead, which markets remdesivir, about pricing for the antiviral drug.   In a Viewpoints article published yesterday in JAMA, Ameet Sarpatwari, PhD, JD, and coauthors noted that FDA’s 1 May emergency use...