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  • Regulatory NewsRegulatory News

    This Week at FDA: Bardoxalone strikes out at adcomm; Updated device consensus standards

    Happy Friday – this week we’re juggling lots of end-of-year activity from the US Food and Drug Administration (FDA). Today and in the next week, look for our contributors to highlight several draft and final guidance documents and to provide analysis and background on industry’s reactions to other guidances whose comment periods have recently closed.   The Center for Drug Evaluation and Research (CDER) released its fall/winter 2021 regulatory science news update today....
  • Regulatory NewsRegulatory News

    MDCG offers new guidance on clinical investigations, importers and distributors

    The European Commission’s Medical Devices Coordination Group (MDCG) on Thursday issued new guidance documents offering questions and answers on the import and distribution of medical devices. The group also provided sponsors with a template for notifying member states of a substantial modification to a clinical investigation, to be used as a stopgap before the Eudamed electronic reporting system is fully functional.   Importers and distributors   In its 11-page que...
  • ReconRecon

    Recon: FDA authorizes Pfizer booster for 16 and 17 year olds; China approves Brii Biosciences’ COVID antibody

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA expands authorization for Pfizer’s Covid-19 booster to cover 16- and 17-year-olds ( STAT ) ( FDA ) AstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease ( WSJ ) ( NYTimes ) ( FDA ) U.S. campaign to vaccinate young children off to sluggish start despite abundant supply ( Reuters ) Becerra names incoming acting NIH dire...
  • ReconRecon

    Recon: Pfizer says vaccine neutralizes Omicron after three doses; FTC settles with Vyera over Daraprim practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, BioNTech vaccine neutralises Omicron with three shots ( Reuters ) ( STAT ) Studies suggest Pfizer shot may protect only partially against Omicron ( Reuters ) Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says ( CNBC ) AbbVie settles New York opioid case as trial winds down ( Reuters ) U.S. FTC settles with Vyera ov...
  • Regulatory NewsRegulatory News

    EMA responds to MEPs’ inquiry on COVID vaccines, data integrity concerns

    The European Medicines Agency (EMA) on Friday responded to an inquiry from several members of the European Parliament (MEPs) concerning the agency’s reviews of the mRNA COVID-19 vaccines developed by Pfizer/BioNTech and Moderna, as well as a report published last month in The BMJ that raised concerns about data integrity at a US trial site for Pfizer’s vaccine.   In her response to the inquiry, sent by MEPs Michèle Rivasi, Piernicola Pedicini and Tilly Metz, EMA Exec...
  • ReconRecon

    Recon: EU agencies recommend mix-and-match COVID vaccines; Biden touts drug pricing plans in social spending bill

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden touts drug pricing plan in push for social spending bill ( Politico ) ( NYTimes ) J&J squares up to Big Pharma rivals with extra RSV vaccine data ( Fierce ) Former Pharma Executive Charged With Embezzling Millions ( AP ) Flagship to launch a new startup focused on neurodegenerative conditions, including Parkinson’s ( STAT ) Targeting prices for accelera...
  • ReconRecon

    Recon: FDA adds warnings on Abbvie, Lilly and Pfizer JAK drugs; EMA recommends Roche arthritis drug for severe COVID

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden’s free at-home test promise could come with added costs ( Politico ) Pfizer could have vaccine data for kids under age 5 by year-end, CEO says ( NBC ) Merck takes aim at Pfizer’s Covid pill as concerns linger over its own drug ( FT ) Documents reveal the secrecy of America's drug pricing matrix ( Axios ) Johnson & Johnson Prepares to Untangle Finances A...
  • Regulatory NewsRegulatory News

    This Week at FDA: Pediatric use for Lilly’s COVID mAbs; Will Woodcock stay on?

    Welcome to month two of our weekly digest of regulatory news from the US Food and Drug Administration (FDA) and other corners of the health care product world. This week saw the expansion of Eli Lilly’s emergency use authorization (EUA) for two of its monoclonal antibodies (mAbs) to treat COVID-19 in pediatric patients and the narrow backing of Merck’s oral COVID-19 antiviral molnupiravir by FDA’s Antimicrobial Drugs Advisory Committee. We’re also reading that Robert Calif...
  • ReconRecon

    Recon: EMA starts rolling review of Valneva’s COVID vaccine; Biden eyes free at-home tests to curb Omicron

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US GSK says tests indicate antibody drug works against Omicron ( Reuters ) ( WSJ ) To fight Omicron, Biden to add travel rules, make at-home COVID tests free ( Reuters ) ( STAT ) Special Report: US rushed contracts to COVID-19 suppliers with troubled plants ( Reuters ) AstraZeneca to Scrap Plan for US Covid Booster Study ( Bloomberg ) BD enters varicose vein tre...
  • ReconRecon

    Recon: FDA advisors narrowly back Merck’s COVID drug; Sanofi to buy Origimm for its acne vaccine candidate

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA advisers narrowly endorse Merck's Covid-19 drug ( Politico ) ( NYTimes ) ( STAT ) FDA finds 'low likelihood' omicron will impact COVID-19 PCR, antigen tests ( MedtechDive ) Testing labs brace for first U.S. cases of Omicron ( Politico ) Prosecutors Push Elizabeth Holmes of Theranos to Take Responsibility ( NYTimes ) ( CNBC ) 23andMe Earmarks Cash From SPA...
  • ReconRecon

    Recon: FDA panel to weigh in on Merck’s COVID antiviral pill; Aspen signs deal for J&J COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters ( FDA ) U.S. FDA panel to weigh Merck's COVID-19 antiviral drug ( Reuters ) ( NYTimes ) ( NPR ) Biden says he will direct FDA, CDC to use ‘fastest process available’ to clear Covid vaccines targeting omicron ( CNBC ) Merck says its COVID-19 drug sh...
  • ReconRecon

    Recon: Califf nomination timeline slips after Biden admin misses paperwork deadline; Canada fully approves J&J COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA nomination slips after Biden admin fails to send papers to Congress ( Politico ) Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies ( STAT ) FDA Approves Takeda's drug for post-transplant CMV infection ( Reuters ) ( FDA ) CVS, Walgreens and Walmart Fueled Opioid Crisis, Jury Finds ( NYTimes ) Elizabeth Holmes Points Finge...