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  • Regulatory NewsRegulatory News

    House spending bill would give FDA drug recall authority

    The US House Committee on Appropriations approved a $3.212 billion budget for the Food and Drug Administration (FDA) on a voice vote Thursday. The budgeted amount is part of the fiscal year 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill, which moved out of the Appropriations Committee on a voice vote.   The bill will now be placed on the calendar for consideration by the full House of Representatives. (RELATED: House prop...
  • Regulatory NewsRegulatory News

    EU agencies urge sponsors to ensure post-Brexit compliance with clinical trial rules

    In a notice issued on Thursday, the European Commission, European Medicines Agency and Heads of Medicines Agencies reminded clinical trial sponsors that they must comply with EU clinical trial rules following the Brexit transition period that expires on 31 December 2020.   With the deadline to extend the transition period now passed, “There is no possibility for further extension beyond that date,” the agencies write, pointing trial sponsors to the Commission’s Brexit ...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on broader cancer trial eligibility

    In four final guidances published today, the US Food and Drug Administration (FDA) outlines cancer trial eligibility criteria considerations for individuals with several specific clinical conditions. Another guidance addresses minimum age considerations for inclusion of pediatric patients in cancer clinical trials.   The guidances, issued jointly by FDA’s Centers for Drug Evaluation and Research and Biologics Evaluation and Research (CDER and CBER), provide considerati...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: Gilead claims remdesivir reduced mortality in Phase 3 study; FDA staff flag ocular toxicities ahead of GSK myeloma drug panel

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Special Report: How the Trump administration secured a secret supply of execution drugs ( Reuters ) Trump will sign three executive orders on lowering drug prices: chief of staff ( Reuters ) Gilead says remdesivir data show reduced risk of death ( Financial Times ) ( Endpoints ) ( Reuters ) ( Press ) FDA Says to Review Side Effect of GSK's Multiple Myeloma Dru...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    As the COVID-19 pandemic continues, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19.   To date, three therapeutics are approved to treat COVID-19: dexamethasone in the  United Kingdom ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan .   Potential therapies are being...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months – if the process goes smoothly from conception to market availability.   The pandemic has created unprecedented public/private partnerships.  Operation Warp Speed  (OWS) is a collaboration of several US ...
  • RoundupsRoundups

    Euro Regulatory Roundup: DKMA allows study drugs to be sent to patients

    Clinical trial sponsors in Denmark can ship investigational medicines directly to study participants under extraordinary measures allowed by the Danish Medicines Agency (DKMA).   Early in the COVID-19 pandemic, DKMA created a document detailing extraordinary measures sponsors can take to mitigate the pandemic’s effect on clinical trials; revisions and expansion over time have resulting in a document with a far wider scope and more lasting impact than the original versi...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS Euro Convergence to be held online and in-person in Brussels, 26–30 October

    RAPS announced today that the format for its Euro Convergence 2020 , taking place 26–30 October in Brussels, has been redesigned as a hybrid online and in-person event. Attendees can now experience Euro Convergence by attending in Brussels at the Radisson Blu hotel and/or virtually via a robust, online platform. The conference, which originally had been scheduled for May, was updated and rescheduled in the wake of the COVID-19 pandemic to allow access to this important Eu...
  • ReconRecon

    Recon: Drugmakers launch $1B antibiotic development fund; Moderna taps Rovi to supply coronavirus vaccine outside US

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US In race to bring vaccine to market, big pharma struggles to protect its intellectual property rights ( CNBC ) Who Gets a Vaccine First? US Considers Race in Coronavirus Plans ( NYTimes ) Grave Shortages of Protective Gear Flare Again as Covid Cases Surge ( NYTimes ) Merck, Eisai's Keytruda-Lenvima combo stonewalled in liver cancer after Roche's first-in-class ...