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    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...
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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...
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    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,...
  • Industry, FDA begin to hammer out PDUFA VII details

    Discussions continue between industry and the US Food and Drug Administration (FDA) regarding the upcoming reauthorization of user fees for prescription drugs, biologics and generic drugs. After public hearing and a first round of meetings that gave a peek into priorities for industry and regulator representatives, this next round began to sort out some detail. (RELATED: PDUFA VII: FDA and industry set priorities in first round of negotiations , Regulatory Focus 29 Octo...
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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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    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...
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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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    FDA lays out 2021 regulatory science areas of focus

    Three strategic initiatives form the backbone of the regulatory science areas of focus for the US Food and Drug Administration in 2021, according to a new report.   The Focus Areas of Regulatory Science (FARS) issued on Monday “outlines topics that the FDA has identified as needing continued targeted investment in regulatory science research to facilitate the development of innovative products, provide data and methodology to inform regulatory decision-making and impro...
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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...
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    EMA okays Europe's second COVID vaccine

    The European Commission has authorized a second vaccine against COVID-19 following a favorable review by the European Medicines Agency’s human medicines committee (EMA’s CHMP). On Wednesday, the messenger RNA (mRNA) vaccine co-developed by Moderna and the US National Institutes of Health was given a conditional marketing authorization.   “With the Moderna vaccine, the second one now authorized in the EU, we will have a further 160 million doses. And more vaccines will ...
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    'N of 1' therapies addressed in draft FDA guidance

    Recognizing the pace at which drug developers are moving ever further into individualized medicine, the US Food and Drug Administration (FDA) has issued a draft guidance addressing submission processes for some hyper-specialized treatments.   The new document, which gives high-level guidance for investigational new drug (IND) submissions of individualized anti-sense oligonucleotides (ASOs), takes into consideration that these “N of 1” therapies come with “a set of chal...
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    Safer technologies program finalized by FDA

    A newly finalized guidance from the US Food and Drug Administration (FDA) smooths the path for manufacturers of devices and device-led combination products that stand to improve the safety of existing treatment and diagnostic options for certain diseases and conditions.   The Safer Technologies Program for Medical Devices (STeP) is intended for devices and combination products that target conditions that are less serious than those covered by FDA’s Breakthrough Devices...