• Regulatory NewsRegulatory News

    FDA explains convalescent plasma donor eligibility for COVID vaccine recipients

    The US Food and Drug Administration (FDA) last week revised its guidance on COVID-19 convalescent plasma to clarify when COVID-19 vaccine recipients can qualify as donors for plasma collected under the agency’s emergency use authorization (EUA) for convalescent plasma.   (RELATED: Lawmakers, experts raise questions after convalescent plasma EUA , Regulatory Focus 25 August 2020; COVID convalescent plasma guidance gets EUA updates , Regulatory Focus 3 Septembe...
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    FDA allows modifications to coagulation monitoring systems for COVID-19

    The US Food and Drug Administration (FDA) is allowing manufacturers to modify coagulation systems for measuring whole blood viscoelastic properties to allow for greater use in hospitals for the supportive management of patients with COVID-19.   The enforcement policy , which was issued in January 2021, is temporary and will remain in effort only for the duration of the COVID-19 public health emergency.   “As hypercoagulability has been observed in patients with CO...
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    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...
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    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 ...
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    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...
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    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...
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    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...
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    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...
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    Hahn offers advice to incoming Biden administration

    With the transition to a new administration less than two weeks away, US Food and Drug Administration (FDA) Commissioner Stephen Hahn on Friday told reporters at an Alliance for Health Policy briefing that he has offered his help to the incoming administration but does not expect to stay on as commissioner.   “I have had the opportunity to talk to transition team and I have certainly offered my willingness to help after the transition in any way that they see fit,” Hah...
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    MHRA okays third COVID-19 vaccine

    As the first week of the new year winds down, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a third vaccine against COVID-19. On Friday, MHRA announced its regulatory approval of the messenger RNA (mRNA) vaccine jointly developed by Moderna and the US National Institutes of Health.   “Having a third COVID-19 vaccine approved for supply following a robust and thorough assessment of all the available data is an important goal to have ac...