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  • Euro Convergence: Navigating changing regulation of drug-device combination products

    As European regulators prepare to implement new requirements for drug-device combination products under the upcoming Medical Device Regulation (MDR), manufacturers and notified bodies are grappling with some of the lingering questions. “There are still some gaps… and some areas where we’d like to see more certainty, but until then we will continue to keep the dialogue going,” Jonathan Sutch, PhD, senior medicinal specialist at the notified body BSI Group, said during a ...
  • Regulatory NewsRegulatory News

    Euro Convergence: Pragmatic approaches to data collection needed to meet MDR

    Manufacturers have a narrowing window of opportunity during which to find pragmatic ways for gathering post-market data to support continued use of products under the Medical Device Regulation (MDR), according to experts who spoke at the Euro Convergence 2020 virtual meeting.   The outgoing Medical Device Directive (MDD) contains scant information on post-market surveillance (PMS) and post-market clinical follow-up (PMCF). MDD contains two uses of the term PMS, creatin...
  • Regulatory NewsRegulatory News

    EMA rolls out implementation plan to address nitrosamine impurities

    The European Medicines Agency (EMA) has rolled out its full plan to implement recommendations to reduce the risk that medicines will be contaminated with nitrosamine impurities, identifying short-, medium- and long-range priorities. The agency has also made templates available for marketing authorization holders to perform risk assessment and confirmatory testing.   The implementation plan builds out a framework for putting in place the specific recommendations of a ...
  • Regulatory NewsRegulatory News

    Euro Convergence: Suboptimal use of MDR grace period is storing up trouble

    Companies are failing to make optimal use of the Medical Device Regulation (MDR) grace period for compliance, adding to the problems created by capacity constraints and tight deadlines, according to experts who spoke at the Euro Convergence 2020 virtual meeting.   In November last year, the European Commission issued a corrigendum to the MDR, allowing manufacturers of certain class I products an additional four years, to 26 May 2024, to comply with the regulation. Unde...
  • ReconRecon

    Recon: Exact Sciences nabs rival Thrive for $2B+; Lilly's COVID antibody flops

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Third wave of coronavirus infections in the U.S.? More like 'wildfire,' epidemiologist says ( NBC ) U.S. Coronavirus Cases Surpass Summer Peak And Are Climbing Higher Fast ( NPR ) Covid hospitalizations rising in 36 states as U.S. hits another record for average new cases ( CNBC ) Fauci on latest surge: 'No matter how you look at it, it's not good news' ( The ...
  • Regulatory NewsRegulatory News

    Euro Convergence: Looming deadlines, regulatory bottlenecks keep EU officials up at night

    The opening plenary session of the Euro Convergence 2020 virtual meeting brought together regulatory professionals from industry, notified bodies and competent authorities. The virtual format, said co-chair  Gert Bos, FRAPS of the Netherlands’ Qserve Group, meant that it was possible to draw together a record 14 individuals for the session.   Co-chair Sabina Hoekstra-van den Bosch, PharmD, FRAPS, asked session participants what is keeping them up at night in 2020, espe...
  • Regulatory NewsRegulatory News

    Breast implant-lymphoma link probed by EC committee

    The European Commission (EC) is seeking public consultation on a new preliminary opinion on the potential association between breast implants and a type of lymphoma, with comments due by 7 December 2020.   The EC’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) issued on report on the relationship between breast implants and anaplastic large cell lymphoma (BIA-ALCL). The committee’s charge encompassed use of implants both for breast reconstru...
  • ReconRecon

    Recon: AstraZeneca’s COVID vaccine packs a wallop; Merck KGaA, partners link for COVID mAbs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Facing vaccine doubts, US grapples with building confidence in coronavirus shots ( BioPharma Dive ) FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines ( STAT ) How pandemic fatigue and polarization led to Wisconsin’s massive Covid-19 outbreak ( Vox ) ( NPR ) Report finds coronavirus pandemic leading to 'unacceptable' shortage of US ...
  • Feature ArticlesFeature Articles

    Making the transition from regulatory manager to regulatory consultant

    This article is about making the transition from company-based regulatory management to regulatory consultancy. It describes the differences between the two roles and provides hands-on, detailed guidance on best practices and how to prepare and tool up for consulting. The author presents a case study demonstrating step by step how a consultant drew on those practices and tools to assist an overseas client in successfully marketing an existing medical device in the US.   ...
  • Feature ArticlesFeature Articles

    US-focused regulatory toolbox: The basics

    This article examines regulatory tools found mostly on the US Food and Drug Administration’s (FDA’s) website for use by regulatory affairs professionals interested in drug products and medical devices marketed in the United States.   FDA guidance documents 1 Guidance documents represent the agency’s current thinking or interpretation of a particular policy or topic. They are an especially useful tool for RA professionals dealing with issues such as drug development ...
  • Regulatory NewsRegulatory News

    IMDRF proposes update on postmarketing device studies

    The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies.   The update outlines when a PMCF study is indicated, the general principles of PMCF studies for medical devices, the design and implementation of studies, and the use of the clinical information. The document does not apply t...
  • Regulatory NewsRegulatory News

    Eudamed: EC posts info on actor registration module

    With less than two months remaining before the Eudamed actor registration module goes live, the European Commission on Tuesday posted a new webpage explaining the steps necessary for actors to register for the database.   The actor registration module is the first of the six Eudamed modules that will launch ahead of the May 2022 date of application for the database and is set to be made available on 1 December 2020. (RELATED: Eudamed actor registration module set to ...