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    The European Medicines Agency (EMA) on Thursday issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion and centralized marketing authorization for medicines they intend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

    Recon: US buys 1.25M more doses of Regeneron COVID antibody drug; Sinovac defends vaccine after latest Brazilian data

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA fights for independence in Trump administration's final days ( Politico ) Johnson & Johnson Expects Vaccine Results Soon but Lags in Production ( NYTimes ) Supreme Court Revives Abortion-Pill Restriction ( NYTimes ) Operation Warp Speed chief resigns at Biden team’s request, will stay through transition, sources say ( CNBC ) US to buy 1.25M additional dos...
  • 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...