• Regulatory NewsRegulatory News

    EMA management board report: COVID coping, CTIS updates and more

    The management board of the European Medicines Agency (EMA) gave a generally positive assessment of the agency’s work through the COVID-19 pandemic, according to recently released highlights of the board’s June meeting.   The board has begun the process of conducting a formal reflection on lessons learned from the pandemic, with a more detailed discussion expected when the board reconvenes in October.   EMA’s board also reviewed the agency’s 2020 annual report publ...
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    FDA issues final guidance on CMC postapproval changes for biologics

    The US Food and Drug Administration (FDA) on Monday issued a final guidance to assist manufacturers of biological products in determining which types of changes to their products should be submitted in an annual report and which will require a prior approval supplement, the highest reporting category.   The guidance contains minor changes from a draft issued in December 2017; no reporting changes were switched from the minor to major category. Licensed biological produ...
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    FDA 'may require' post-marketing studies to analyze long-term effects of breast cancer drugs

    The US Food and Drug Administration (FDA) "may require” or seek agreement from sponsors to conduct post-marketing studies to analyze long term effects of breast cancer drugs in both pre- and post-menopausal women in a final guidance issued on 17 June. The guidance also provides other considerations for sponsors as they plan for the inclusion of premenopausal women in clinical trials of drugs for breast cancer treatment.   According to the agency’s announcement of the f...
  • ReconRecon

    Recon: Supreme Court rebuffs Amarin, Abbvie in separate rulings; Moderna to ramp up vaccine production

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Supreme Court rebuffs insurers on Obamacare reimbursements ( Reuters ) Supreme Court denies Amarin's bid to revive Vascepa drug patents ( Reuters ) Supreme Court rebuffs AbbVie appeal in patent fight involving AndroGel drug ( Reuters ) ( Law360 ) Moderna plans to expand COVID-19 vaccine production ( Reuters ) ( WSJ ) HHS backs down in legal fight over drug di...
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    MDUFA V: FDA proposes TPLC advisory panel, industry says ‘back to basics’

    Minutes from the latest round of negotiations between the US Food and Drug Administration (FDA) and industry around the next iteration of the Medical Device User Fee Amendments (MDUFA V) have been released to the public and highlight how stakeholders are approaching the talks with different goals in mind.   Negotiations for MDUFA V began this year after months of delays due to the COVID-19 pandemic. Last year, a public kick-off meeting was pushed from April 2020 to Oct...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    More than a year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   Regulators around the world have allowed a handful of treatments to be used on an emergency-use basis including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with etesevimab; Regeneron’s casirivimab and imdevim...
  • ReconRecon

    Recon: Sen. Manchin opposes Woodcock for FDA Commissioner; BMS, Eisai in $3.1B cancer drug development deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sen. Manchin to Biden: Don't nominate Woodcock for FDA commissioner ( Endpoints ) ( The Hill ) ( Letter ) Over 300 cases of heart issue after Covid vaccination reported in young people, CDC says ( NBC ) White House to finish allocating 80 mln U.S.-made COVID-19 shots for shipment abroad ( Reuters ) Analysis: Rival treatments may help justify FDA gamble with Bi...
  • Feature ArticlesFeature Articles

    EU IVDR compliance in a small organization

    This article presents a brief overview of the EU In Vitro Diagnostic Regulation (IVDR) requirements. It provides a user-friendly, step-by-step guide on how to comply with the regulation from first-hand experience and includes suggestions and tips for IVDR compliance through the lens of a small organization.   Understanding the changes of EU IVDR The IVDR, or Regulation 2017/746, 1 on in vitro diagnostics (IVDs) came into effect with its publication on 26 May 2017 ...
  • EC proposes crisis-related devices role for EMA

    The European Council (EC) has proposed that the European Medicines Agency (EMA) take a stronger role in crisis management and preparedness, increasing its administrative oversight of medicinal products and also medical devices during emergencies such as the recent COVID-19 pandemic.   The proposal, first drafted in November 2020, is part of a triad of documents “aiming to strengthen the EU's health security framework and to reinforce the crisis preparedness and respons...
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    FDA explains when device 'servicing' becomes 'remanufacturing'

    At what point does manipulation or repair of a medical device cross the line from “servicing” to “remanufacturing?” A new draft guidance from the US Food and Drug Administration (FDA) provides a set of considerations to aid in determining into which category actions performed on devices should fall.   The new draft guidance “helps clarify whether activities performed on devices are likely remanufacturing,” wrote FDA’s Center for Devices and Radiological Health (CDRH) i...
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    Unified Agenda: A look at FDA’s upcoming rulemaking

    Under the Biden administration’s first regulatory agenda, the US Food and Drug Administration (FDA) is preparing to promulgate three dozen proposed and final rules related to human drugs, biologics, medical devices and clinical trials.   The proposed and final rules are detailed in the belated Spring 2021 unified agenda released by the Office of Management and Budget last week. Many of the rules are holdovers from previous biannual agendas, such as a final rule on the ...
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    EMA updates COVID-19 vaccine risk management plans to reflect variant safety

    The European Medicines Agency (EMA) wants companies to provide safety information on additional strains or variants in an update to its guidance on risk management plans (RMPs) for COVID-19 vaccines. In the update, EMA also discourages sponsors from using passive surveillance to evaluate vaccine safety due to a lack of robustness in these methods.   The plan should be read in conjunction with EMA guidance on good pharmacovigilance practices, including GVP Module V, Mod...