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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

    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...
  • 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...
  • 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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    More metformin recalled for NDMA; 6 firms now affected

    Two manufacturers have announced voluntary recalls of metformin formulations containing elevated levels of a potential carcinogen.   Granules Pharmaceuticals, based in Virginia, has issued a recall for its extended-release metformin, although just one of 12 batches tested exceeded acceptable levels of N-nitrosodimethylamine (NDMA) in the firm’s testing. The recall includes 100- and 500-count bottles of 750 mg metformin tablets.   Separately, India-based Lupin Pha...
  • RoundupsRoundups

    FDA Approvals Roundup: Rukobia, Byfavo, Inqovi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rukobia gets the green light for hard-to-treat HIV ViiV Healthcare’s Rukobia (fostemsavir) has been approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant infection whose current antiretroviral regimen is ineffective because of resistance, intolerance, or safety concerns.   The drug, a ...
  • ReconRecon

    Recon: EU reportedly strikes deals for Roche, Merck KGaA COVID drugs; Biogen submits aducanumab BLA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump administration submits formal notice of withdrawal from WHO ( STAT ) ( WSJ ) Pence, Azar reassure governors Trump won't end virus emergency declaration ( Politico ) Drug prices steadily rise amid pandemic, data shows ( Politico ) In a test for Hahn's FDA, Biogen submits controversial Alzheimer's drug aducanumab ( Fierce ) ( Endpoints ) ( BioPharmaDive ) ...
  • Regulatory NewsRegulatory News

    Unified agenda: FDA publishes lengthy to-do list

    Two final rules top the Spring 2020 regulatory agenda for the US Food and Drug Administration (FDA), addressing the importation of prescription drugs and the de novo classification process for medical devices. The agency’s unified agenda overall is mammoth and includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.   The importation of prescription drugs continues to be among deregulatory priorities for the Tr...