• 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...
  • 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    The European Medicines Agency (EMA) on Thursday issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion and centralized marketing authorization for medicines they intend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...
  • Regulatory NewsRegulatory News

    In 2020, all goal dates met for CDER's novel approvals

        Editor’s note: come back to Regulatory Focus tomorrow for an expanded examination of these approvals, including which sponsors made use of expedited programs, and which programs were used most frequently.   A slate of 53 drugs makes up the list of novel drugs approved by the US Food and Drug Administration in 2020. The list, released Wednesday, includes such notables as Veklury (remdesivir, Gilead), a shelved antiviral repurposed to treat COVID-19 infection,...
  • Regulatory NewsRegulatory News

    European Commission appoints members to MDR/IVDR expert panels

    The European Commission this week released the names of members appointed to its 12 expert panels on medical devices and in vitro diagnostics (IVDs).   The expert panels, established under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will provide scientific, technical and clinical input to the Commission, its Medical Device Coordination Group (MDCG), member states, notified bodies and manufacturers. In particular, notified bodies ...
  • Regulatory NewsRegulatory News

    EMA considers AstraZeneca vax; Swissmedic okays Moderna's

    The European Medicines Agency (EMA) could issue an opinion on the COVID-19 vaccine co-developed by AstraZeneca and the University of Oxford as early as 29 January, according to a press release the agency issued on Tuesday.   The agency announced that it has received the full application packet for conditional marketing authorization of the chimpanzee adenovirus vector vaccine following a rolling review that began 1 October.   The AstraZeneca vaccine, already author...
  • Regulatory NewsRegulatory News

    EC clears path for remote audits by notified bodies

    Remote audits will be an option during the pandemic for some European medical device and in vitro diagnostic manufacturers, following an announcement from the European Commission (EC).   The temporary step takes into account the “exceptional and unforeseen circumstances caused by the COVID-19 crisis,” according a notice issued by the EC on Monday. Both industry and notified bodies had felt hamstrung by the complete stall in inspections caused by the coronavirus pande...
  • Regulatory NewsRegulatory News

    HHS pushes through last-minute policies impacting FDA

    With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that could impact the US Food and Drug Administration’s (FDA) regulatory oversight.   Last week, HHS announced it had finalized a rule that would cause its regulations to expire if they are not reviewed every 10 years, with some exceptions provided for medical device-specific regulations, food standards and over-the-cou...
  • Regulatory NewsRegulatory News

    Updated: Documents leaked to the internet in wake of EMA cyberattack

    Editor's note: This article was updated 12 January 2021 to include information provided in EMA's fourth update on this cyberattack.  Some of the COVID vaccine-related documents obtained during an early December 2020 cyberattack on the European Medicines Agency (EMA) made their way to the internet, according to the agency's fourth update on the matter. EMA's ongoing investigation has shown that "some of the unlawfully accessed documents related to COVID-19 medicines an...