Antimicrobial resistance (AMR) has emerged as one of the most critical global health challenges, threatening the effectiveness of existing therapies and complicating the management of infectious diseases. The increasing prevalence of resistant pathogens has created an urgent need for innovative diagnostic tools, novel antimicrobials, and effective stewardship strategies. However, the regulatory landscape governing antimicrobial products—particularly antimicrobial susceptibility testing (AST) devices, companion diagnostics, and drug–device combinations—remains complex and fragmented. Regulatory agencies such as the FDA and WHO have developed frameworks to facilitate the evaluation and approval of AMR-related technologies, yet challenges persist in harmonizing standards, validating performance, and ensuring timely access to critical interventions.
Strengthening the integration of regulatory pathways for both medical devices and pharmaceuticals is essential to accelerate innovation, improve diagnostic accuracy, and support global efforts to mitigate the spread of antimicrobial resistance while safeguarding public health.
The goal of this Research Topic is to critically examine the regulatory strategies and frameworks that govern the evaluation, approval, and post-market oversight of AMR–related products, including antimicrobial susceptibility testing (AST) devices, companion diagnostics, and drug–device combination products. As AMR continues to pose a global health threat, efficient regulatory mechanisms are essential to support the rapid development and deployment of innovative diagnostic and therapeutic solutions.
This Research Topic aims to analyze how major regulatory bodies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO), are addressing AMR through adaptive regulatory pathways and cross-sectoral collaboration. The studies will assess the effectiveness of current approval processes, identify key gaps in harmonization, and explore opportunities for integrating device and drug evaluation frameworks.
Ultimately, this Research Topic seeks to propose evidence-based recommendations to enhance regulatory preparedness, streamline product review timelines, and promote global alignment in combating antimicrobial resistance through innovation, compliance, and coordinated policy action.
Topics of interest include, but are not limited to:
• antimicrobial susceptibility testing (AST) devices • companion diagnostics • drug–device combination products • FDA, EMA, and WHO policies and approaches aimed at accelerating the approval of tools for: early detection, treatment optimization, and surveillance of resistant pathogens • harmonization of regulatory standards
Manuscripts should focus on scientific, technical, and policy aspects of medical product regulation, including drugs, biologics, devices, diagnostics, digital health technologies, and combination products. Submissions highlighting regulatory harmonization, global convergence, quality management, and risk-based approaches are especially welcome.
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