• Regulatory NewsRegulatory News

    Cyberattack: EMA says leaked documents ‘manipulated’

    Documents related to COVID-19 vaccines that were unlawfully accessed in a cyberattack against the European Medicines Agency (EMA) and subsequently leaked online were intentionally manipulated, the agency said on Friday.   EMA first disclosed the hack in December and said at the time it had launched a full investigation in cooperation with law enforcement and other authorities. Since then, vaccine frontrunners Pfizer and BioNTech and Moderna have released statements ack...
  • Regulatory NewsRegulatory News

    FDA issues guidance on resuming or initiating BE studies amid pandemic

    New guidance from the US Food and Drug Administration (FDA) issued on Friday provides recommendations for resuming or initiating bioequivalence (BE) studies for generic drugs during the COVID-19 pandemic.   The guidance, aimed at ensuring participant and study staff safety, calls on generic drug developers to carefully consider protocols for resuming or initiating BE studies and to take steps to ensure the scientific validity of data generated from studies impacted by ...
  • Regulatory NewsRegulatory News

    PREPP initiative: FDA’s COVID-19 response and the path forward

    The US Food and Drug Administration (FDA) has adapted in its response to the COVID-19 pandemic, from increasing transparency of its risk-benefit analyses for emergency use authorizations (EUAs) to providing guidance on vaccine development, according to a summary report of the agency’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative.   The report catalogues the agency’s work during the pandemic, noting that it has published and revised more than 65...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the  United Kingdom  and  Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in the United States ,  Japan  and Australia.   Three therapeutics have received emergency use authorizations (EUAs) in the US. Convalescent plasma, which was authorized by the Food and Drug Administration (FDA) on 23 August and is subject to updated...
  • ReconRecon

    Recon: Trump admin eyes term limits on top health jobs; Pfizer temporarily reduces vaccine shipments

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vaccine reserve was already exhausted when Trum administration vowed to release it ( Washington Post ) Trump admin races to enact term limits for top health scientists ( Politico ) Trump wants billions cut from global Covid vaccine distributor ( Politico ) Former FDA commissioner: "Reliable drug supply is absolutely critical" ( Axios ) Biden taps D.C. veteran...
  • Regulatory NewsRegulatory News

    FDA sped progress for most of 2020's novel drugs

    Most novel drugs approved by the US Food and Drug Administration (FDA) in 2020 made their way through the approvals process using one or more expedited approval pathways, and over half of sponsors received the incentives that accompany orphan drug designation, according to an FDA report detailing the year’s approvals.   Novel drug approvals continued at a brisk clip, averaging over one per week in 2020. Despite the pandemic the 53 novel drugs approved in 2020 bested 20...
  • Regulatory NewsRegulatory News

    EMA offers parallel Article 58, centralized authorization reviews

    The European Medicines Agency (EMA) on Thursday issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion and centralized marketing authorization for medicines they intend to market in the EU and abroad.   The Article 58 procedure allows EMA’s Committee for Medicinal Products for Human Use (CHMP) to give opinions in cooperation with the World Health Organization (WHO) on medicines intended to be used in low- an...
  • Regulatory NewsRegulatory News

    FDA issues potency testing guidance for COVID antibody treatments

    Amid the coronavirus pandemic, the US Food and Drug Administration has issued guidance on potency assays for manufacturers of monoclonal antibodies and other therapeutic proteins to treat COVID-19. The guidance is immediately effective for the duration of the public health emergency.   In the ordinary course of business, FDA would have engagement with drug developers to work on potency assays “over a span of years.” However, according to the guidance, “given the compre...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. A handful of vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker now has been split in two. The first chart details vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in e...
  • Feature ArticlesFeature Articles

    Soft skills training during a pandemic: Why it’s important, and how to do it

    In this article, the author discusses the importance of soft skills training during the COVID-19 pandemic in the context of their role in defining one’s employability and advancing both personal and team success in achieving goals. These training sessions will give employees an opportunity to connect virtually with their colleagues, improve morale, and provide skills that will increase productivity and create a more positive working environment. The article provides tools ...
  • ReconRecon

    Recon: Woodcock expected as acting FDA commissioner; J&J vaccine induces immune response in early trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Woodcock to serve as acting FDA commissioner, Sharfstein a contender for top FDA job ( BioCentury ) ( Endpoints ) ( Bloomberg ) Biden’s Covid board in the dark on final vaccine plan ( Politico ) Data fuel debate over whether J&J’s one-dose Covid vaccine will measure up ( STAT ) ( Bloomberg ) ( NEJM ) J&J vaccine on track for March rollout with target to delive...
  • RoundupsRoundups

    Euro Roundup: UK rejects new agency to redress drug, device harms

    The UK government has rejected a call to establish an independent redress agency. Baroness Cumberlege, a Conservative party member of the House of Lords, called for the government to create the agency after her review of patient safety in the UK identified a need for a new way to remedy harms caused by some medicines and medical devices.   Last year, the Independent Medicines and Medical Devices Safety Review advised the government to set up an independent redress agen...