Tag: Regulatory Science
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EMA ETF Improves Scientific Advice for Medicines and Vaccines Tackling Public Health Threats
Background: A New Era for Public Health Medicines The European Medicines Agency’s Emergency Task Force (ETF) is reforming how it provides scientific advice to developers working on medicines and vaccines for urgent public health threats. This initiative aims to streamline the path from early development to clinical evidence, with a particular focus on antimicrobial resistance…
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EMA ETF Refines Scientific Advice for Antimicrobial Resistance Medicines and Public Health Threats
Enhancing Guidance for Medicines in Public Health Emergencies The European Medicines Agency’s (EMA) Emergency Task Force (ETF) is upgrading its approach to providing scientific advice for the most promising medicines and vaccines in development to combat public health threats. This evolution focuses on ensuring that life-saving therapies are developed with robust regulatory input, especially in…
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Improved Scientific Advice for Medicines Tackling Public Health Threats, Including Antimicrobial Resistance
Raising the Bar for Medicines and Vaccines against Public Health Threats Public health threats evolve rapidly, from novel pathogens to the growing challenge of antimicrobial resistance (AMR). In response, the European Medicines Agency’s Emergency Task Force (ETF) is refining its approach to provide higher-quality, earlier scientific advice for medicines and vaccines under development. The aim…
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Booze Without the Burn: How an Enzyme-Tinkering Startup Aims to Make Spirits Smoother
Introduction: A New Route to Smoother Spirits In a world where professional spirit tastings often celebrate bold, characterful profiles, the average consumer looks for something different: a smoother sip that doesn’t punish on the way down. A new breed of startup is betting that the answer lies in enzyme engineering rather than aging longer in…
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Global standard for dengue treatment trial outcomes published
New global standard harmonizes dengue trial outcomes A world-first global standard for measuring outcomes in dengue treatment trials has been published in The Lancet Infectious Diseases this week. Co-led by researchers at King’s College London and the University of Oxford, the work resolves a long-standing inconsistency in what is evaluated and reported across dengue clinical…
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Global standard for dengue trial outcomes: a new consensus to accelerate therapies
Groundbreaking move in dengue research A landmark publication in The Lancet Infectious Diseases announces the first global standard for measuring outcomes in dengue treatment trials. Co-led by researchers from King’s College London and the University of Oxford, the work represents a concerted effort to harmonize what researchers should measure when testing therapies for dengue fever.…
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Global standard for dengue trial outcomes established worldwide
A landmark step in dengue research The first global standard for measuring outcomes in dengue treatment trials has been published in The Lancet Infectious Diseases this week. Co-led by researchers from King’s College London and the University of Oxford, the study resolves a long-standing mismatch in how outcomes are defined and reported across trials. By…
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EU Stakeholder Perspectives on Early Feasibility Studies for Digital Health
Understanding the Regulatory Context for Digital Health in the European Union Digital health technologies (DHTs) — from mobile apps and wearables to AI-driven decision aids — are transforming how care is delivered. In the EU, these tools face a software-focused regulatory environment under the Medical Device Regulation (MDR) and an evolving AI framework. A growing…