• 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...
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    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...
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    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   The final document supersedes a draft guidance that was issued in July 2018.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...
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    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...
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    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...
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    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...
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    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...
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    Recon: J&J forecasts $2.5B in 2021 COVID vaccine sales; South Africa’s Biovac to make Pfizer-BioNTech vaccine in 2022

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Anthem still determining coverage policy for Biogen Alzheimer's drug ( Reuters ) Biogen Alzheimer's drug slow to take off as US Medicare wrestles with coverage ( Reuters ) Drugmakers, pharmacies next targets for US opioid settlements ( Reuters ) Former FDA adviser calls for wider probe into Biogen Alzheimer's drug approval ( Reuters ) J&J forecasts $2.5 bln i...
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    EMA begins rolling review of Sanofi Pasteur COVID vaccine

    The European Medicines Agency (EMA) has taken a fifth COVID-19 vaccine candidate into its rolling review scheme, evaluating data as they become available to speed a regulatory decision amid the ongoing public health emergency of the COVID-19 pandemic.   EMA’s decision to evaluate Sanofi Pasteur’s Vicprevtyn vaccine by rolling review is based on non-clinical data and early clinical studies “which suggest that the vaccine triggers the production of antibodies that target...
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    Senators press Woodcock on COVID vaccines, boosters

    Senators on both sides of the aisle pressed Janet Woodcock, acting commissioner of the US Food and Drug Administration (FDA), and other officials during a hearing on Tuesday. The senators asked for specifics on the timing of COVID-19 vaccine booster shots and when the vaccines currently authorized for emergency use might obtain full approval.   More than a year into the COVID-19 pandemic, the full Senate Health, Education, Labor and Pensions committee met to explore th...