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Achieving Regulatory Alignment for Anti-Infective Clinical Trials
Sumathi Nambiar1, Marco Cavaleri2, Junko Sato3
1Division of Anti-Infectives, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States.
Abstract:
The growing concern of antimicrobial resistance coupled with the dearth of new antibacterial agents in development is a major public health threat. Multiple stakeholder efforts are underway to address the various challenges facing this field; while some progress has been made, antibacterial drug development continues to be a challenging area. The economic issues encountered in this space are probably today the most cogent; however, there are many other aspects that continue to pose challenges to enterprises engaging in this area, from the difficulties in discovering and advancing new classes of products to scientific issues with clinical trial design and feasibility in conducting these trials.
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