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  • Regulatory NewsRegulatory News

    FDA clarifies pooled sample, multi-analyte coronavirus EUAs

    Developers of multi-analyte respiratory panels that include a test for SARS-CoV-2, the novel coronavirus, can request emergency use authorizations (EUAs) from the US Food and Drug Administration (FDA), the agency clarified this week.   In updates to its frequently asked questions (FAQ) webpage on SARS-CoV-2 testing, the agency said that multi-analyte respiratory panels that include SARS-COV-2 are eligible for emergency use authorization, noting “the overlap in signs ...
  • Regulatory NewsRegulatory News

    Global regulators agree on endpoints for COVID-19 therapeutics

    Regulators participating in the International Coalition of Medicines Regulatory Authorities (ICMRA) last week reached a consensus on endpoints that would be acceptable as primary endpoints in randomized controlled trials for therapeutics to treat coronavirus disease (COVID-19).   In a teleconference on 20 July 2020 co-chaired by the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), ICMRA members reviewed potential endpoint...
  • Regulatory NewsRegulatory News

    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...
  • ReconRecon

    Recon: US to pay $2.1B for Sanofi, GSK COVID-19 vaccines; AbbVie, Gilead report Q2 results

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to pay $2.1B to Sanofi, GSK, in COVID-19 vaccine deal ( Reuters ) ( Politico ) ( NYTimes ) ( Press ) Trump planning for US rollout of coronavirus vaccine falling short, officials warn ( Reuters ) Large US COVID-19 vaccine trials will exclude pregnant women for now ( Reuters ) Merck plans large trials of antiviral COVID-19 drug in September ( Reuters ) Chin...
  • 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 and Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan  and Australia.   Pot...
  • Regulatory NewsRegulatory News

    Glycolic acid, TCA among proposed additions to 503B bulk drugs list

    Four new bulk substances are up for inclusion on the list of active pharmaceutical ingredients that outsourcing facilities can use in drug compounding under section 503B of the Federal Food, Drug, and Cosmetic Act , according to a proposal from the US Food and Drug Administration (FDA).   The four substances FDA is proposing to include as bulk drug substances are diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester and trichloroacetic acid. An additiona...
  • 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: MHRA creates synthetic dataset to support COVID-19 research

    The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has created a synthetic dataset to support development of medical technologies for use in the response to COVID-19.   Developers of machine learning algorithms need health data to validate and benchmark their technologies. However, the strict regulation of even pseudonymised data, and lingering privacy fears related to its use, make it hard and expensive for researchers to access the resource...
  • ReconRecon

    Recon: J&J begins its first COVID-19 vaccine clinical trial; AstraZeneca reports rise in first-half profit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers Race to Build Covid-19 Vaccine Supply Chains ( WSJ ) FDA could issue emergency use authorization for coronavirus vaccine in a matter of weeks ( CNN ) FDA Nears Decision Authorizing Covid-19 Treatment With Convalescent Plasma ( WSJ ) J&J starts human study of COVID-19 vaccine after promising monkey data ( Reuters ) ( FT ) ( NYTimes ) Inovio vaccine ...
  • Regulatory NewsRegulatory News

    FDA issues new unit-dose repackaging guidance

    Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions, so long as certain requirements are met.   The agency issued the guidance in the context of the increasingly common practice of repackaging solid oral medications into unit-dose containers for hospitals and long-term care facilities. “The increase in unit dose repackaging has led to questions...
  • Feature ArticlesFeature Articles

    A military-civilian perspective on real-world evidence to support regulatory decision making

    This article summarizes the framework promoting the collection and analysis of real-world data (RWD) in the healthcare system. The authors emphasize how the US Military Health System (MHS) used RWD during the Iraq and Afghanistan Wars to achieve historic rates of survival and describe a new era of collaboration between the US Department of Defense (DoD) and the US Food and Drug Administration (FDA). The article reviews the FDA evidentiary standards for medical product appr...
  • Regulatory NewsRegulatory News

    FDA issues at-home and OTC COVID-19 testing template

    Developers of COVID-19 diagnostic tests designed for at-home and over-the-counter use have a new template they can use to submit emergency use authorization (EUA) requests to the US Food and Drug Administration (FDA).   For at-home testing, the template includes recommendations for developers in the scenario where samples are collected, analyzed, and results returned without the sample being sent to a laboratory for analysis. Additional validation recommendations are...