• TrackersTrackers

    COVID-19 therapeutics tracker

    A year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for a handful of treatments including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with etesevimab as well as Regeneron’s casirivi...
  • Regulatory NewsRegulatory News

    Health Canada drafts guidance on electronic media in labeling

    Health Canada last week launched a public consultation on its draft guidance for drugmakers on incorporating electronic media, such as websites or mobile applications, in prescription drug labeling.   The public consultation runs until 7 May 2021 and seeks feedback from industry, health professionals and the public on the agency’s proposed guidance. The draft guidance is built around Health Canada’s existing legal framework for labeling and explains the agency’s expect...
  • 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

    Modernizing clinical trial regulations in Canada

    This article provides an overview of Health Canada’s plans to modernize its clinical trials regulations and enhance health care agility in the regulatory framework for its health care products by making regulations more flexible and adaptive to innovation. The author discusses how clinical trials in several health care product lines can be modernized and looks at how lessons learned from the COVID-19 pandemic experience can help set up a more flexible regulatory framework ...
  • RF Quarterly

    The Canadian application process and alternate pathway for COVID-19‒related 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 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 of clinical trial submission requirements and communication with Health Canada’s relevan...
  • Regulatory NewsRegulatory News

    How to handle COVID variants? Global regulators turn to flu vaccines

    A global consortium of regulators is turning to seasonal influenza vaccine authorization as a model for how to address variant-adjusted version of authorized COVID-19 vaccines.   New guidance available from the ACCESS consortium, including the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), directs vaccine developers to focus on demonstrating robust immune response against new variants when trialing modified COVID-19 vaccines. In addition...
  • Regulatory NewsRegulatory News

    EMA, Health Canada publish Moderna data package

    Making good on an earlier commitment to transparency in regulatory decision-making during the COVID-19 pandemic, the European Medicines Agency (EMA), in collaboration with Health Canada, has published the full clinical data package upon which the regulators based their approvals of the COVID-19 vaccine jointly developed by Moderna and the US National Institutes of Health.   The Tuesday announcement of the availability of the data package “highlights the shared commitme...
  • Regulatory NewsRegulatory News

    England and Canada diverge from US on cancer drug decisions

    Regulatory and health technology assessment agencies in Canada and England are diverging from the US when it comes to oncology drugs. But they often rely on the same surrogate endpoints to make their decisions, according to two new analyses published in JAMA Internal Medicine .   The first study , led by Avi Cherla, MSc, of the London School of Economics and Political Science, revealed that among 68 cancer indications with accelerated approval in the US that also rec...
  • 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...
  • Regulatory NewsRegulatory News

    New toolbox available for EMA's PRIME designees

    The European Medicines Agency has released a draft guidance to assist drug developers using its Priority Medicines (PRIME) scheme to accelerate authorization of new therapies.   “Experience to date has shown that applicants face challenges to complete quality and manufacturing development and data requirements during development of products in early access approaches,” wrote EMA in the executive summary of the guidance.   Challenges for those developing breakthroug...
  • Regulatory NewsRegulatory News

    Perspective: Drug price transparency in the Biden era

    The Trump administration’s efforts to increase drug price transparency are likely to survive the transition to the Biden administration, according to a perspective piece published 13 January in the New England Journal of Medicine . Included in the Transparency in Coverage final rule, issued in late October 2020, the drug price transparency provisions aim to require that health insurers publish list prices and historical net prices for prescription drugs. The inform...
  • Regulatory NewsRegulatory News

    Health Canada greenlights Moderna's COVID vaccine

    Health Canada has authorized a second vaccine against COVID-19, granting Moderna marketing authorization with conditions for the messenger RNA (mRNA) vaccine it co-developed with the US National Institutes of Health.   The authorization for use in individuals aged 18 years and up follows Health Canada’s 9 December authorization of the mRNA COVID-19 vaccine developed by Pfizer and the German firm BioNTech. Both vaccines’ authorizations were issued under an interim or...