• Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost 20 vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker 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 early de...
  • RoundupsRoundups

    Euro Roundup: EU launches survey for COVID-19 drug developers

    The EU is holding a survey to understand the needs of companies developing new and repurposed treatments for COVID-19. The follows the European Commission’s recent strategy to support the approval of up to five new COVID-19 drugs by the end of the year.   (RELATED: EC strategy aims for 3-5 new COVID therapeutics by year end , Regulatory Focus 6 May 2021)   In the survey, the EU asks for information about the COVID-19 therapies companies are developing, includi...
  • ReconRecon

    Recon: Becerra signals more time needed to nominate FDA chief; CureVac vaccine disappoints in pivotal trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More Time Needed on FDA Pick, Becerra Says ( Bloomberg ) ( Endpoints ) US Supreme Court rejects Republican challenge to Obamacare law ( Reuters ) ( KHN ) ( NYTimes ) Vaccine Maker Earned Record Profits but Delivered Disappointment in Return ( NYTimes ) ACIP readies Friday meeting on vaccine safety, boosters ( Politico ) Blueprint Medicines nabs 4th approval i...
  • RoundupsRoundups

    FDA Approvals Roundup: StrataGraft, Rezipres, Trikafta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals StrataGraft greenlighted for treating thermal burns in adults Mallinckrodt’s StrataGraft has been approved as a topical application treatment for adults with thermal burns containing intact deep skin layers for which surgical intervention is clinically indicated.   Deep thermal burns often require the removal of damaged skin and replacement ...