• Feature ArticlesFeature Articles

    RWD, RWE, and improved patient outcomes: From FDA's Mini-Sentinel to real-world examples

    Uses of real-world data and evidence (RWD and RWE) have proliferated in recent years, driven by advances in data-gathering tools and methods and enhanced understanding of the value of such data and evidence. Under the 21st Century Cures Act of 2016, Congress codified RWD and RWE in the drug development and approval process. There are many opportunities for the use of RWD and RWE in the approval, labeling, clinical use, and marketing of medical products to enhance individu...
  • ReconRecon

    Recon: US buys 200M more doses of Pfizer vaccine; European Commission opens in-depth investigation into Illumina's bid to acquire Grail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US United States buys 200 mln more doses of Pfizer/BioNTech COVID-19 vaccine ( Reuters ) CDC advisers hold off on Covid booster shot call ( Politico ) ( WSJ ) U.S. CDC advisers back J&J COVID-19 vaccine benefits amid neurological illness reports ( Reuters ) Facing Headwinds on New Alzheimer’s Drug, Biogen Launches Controversial Campaign ( KHN ) AstraZeneca's onc...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost two dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that are au...
  • Regulatory NewsRegulatory News

    EC announces €120 million in Horizon Europe funding

    The European Commission (EC) has pruned the list of COVID-19-related research projects it plans to fund, announcing Thursday a short list of 11 projects that will receive €120 million in total.   Funding for the projects will come from Horizon Europe, a research and innovation program that launched in 2021 and is planned to sunset by 2027. The program supports “urgent research” into COVID-19 with a focus on the emerging threats of variants of SARS-CoV-2, according to...
  • Regulatory NewsRegulatory News

    Woodcock: FDA needs expanded authority on device shortages

    The US Food and Drug Administration's (FDA) Acting Commissioner Janet Woodcock on Wednesday made a push for new funding to increase the resilience of the medical device supply chain and to expand the agency's authority to collect information about device shortages.   "The pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices. To ensure the US is properly prepared now, and in the future, we must take actio...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on field alert reports

    The US Food and Drug Administration on Thursday finalized guidance on its expectations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in submitting field alert reports (FARs) for potentially defective drugs. It contains only minor changes from the draft.   The final document supersedes a draft guidance that was issued in July 2018. (RELATED: Field Alert Report Submissions: FDA Offers Draft Q&A , Regulatory Focus 19 Jul...
  • Regulatory NewsRegulatory News

    CDRH official offers advice for smoother Q-submission meetings

    A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings, as well as best practices for ensuring smooth reviews.   Susannah Gilbert, Q-submission program lead with the division of regulatory programs at FDA’s Center for Devices and Radiological Health (CDRH), gave the updates at a 21 July webinar sponsored by the FDA’s Small Business Regulatory Education for Industry...
  • ReconRecon

    Recon: Roche in talks with FDA on Alzheimer's candidate; Pfizer bets $1B on Arvinas' protein degrader

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Roche in talks with FDA on Alzheimer's candidate, says CEO ( Reuters ) States reach $26 billion deal with three wholesalers and J&J to end opioid lawsuits ( STAT ) ( NYTimes ) Merck, Eisai notch full approval for Keytruda-TKI inhibitor combo in advanced endometrial cancer ( Endpoints ) ( FDA ) Pfizer bets $1B cash on the original protein degraders as technolog...
  • RoundupsRoundups

    Euro Roundup: MHRA misses multiple performance targets due to COVID-19, CAP grandfathering

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) missed several performance targets last year as it contended with challenges including COVID-19. A target for the production of validation reports for marketing authorization applications was among the missed objectives.   MHRA aims to produce a validation report for a new marketing authorization application within 14 days of case creation 97% of the time. In its 2020 to 2021 fiscal year, MHRA hit that d...
  • Regulatory NewsRegulatory News

    FDA seeks global shift to include pregnant women in medical research

    The COVID-19 pandemic has put a spotlight on the paradox surrounding the inclusion of pregnant and breastfeeding women in medical research. Even when these women are at higher risk for severe illness and hospitalization, they are unlikely to be included in clinical trials for medical products and vaccines. In a recent article, officials at the US Food and Drug Administration (FDA) signaled their commitment to work with industry and other regulators to support the inclus...
  • Regulatory NewsRegulatory News

    House committee advances bills on advanced manufacturing, opioids and more

    Following a brief markup on Wednesday, the House Energy and Commerce Committee advanced 24 bipartisan health- and cybersecurity-related bills to the House for consideration, including bills aimed at advanced and continuous manufacturing for pharmaceuticals, supporting vaccination and addressing the ongoing opioid crisis. The first bill to be considered during the markup would amend the 21 st Century Cures Act to enable the US Food and Drug Administration (FDA) to des...
  • RoundupsRoundups

    FDA Approvals Roundup: Rezurock, Fexinidazole, Bylvay

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rezurock cleared for treating chronic graft-versus-host disease Kadmon’s Rezurock (belumosudil) has been approved for treating chronic graft-versus-host disease (GVHD) in adults and children aged 12 years or older after failure of previous systemic therapy.   Approval of the kinase inhibitor was based on efficacy findings from the randomized...