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• W2022657122 abstract "The development of antimicrobial drugs has evolved from observational case reports to complex randomized prospective clinical trials in specific treatment indications. Beginning around the year 2000, the US FDA has evolved its approach on study design and other study characteristics, which has made the conduct of these studies more difficult and the outcomes for sponsors more risky. This has contributed to the decline in the discovery and development of new antimicrobials, which are needed to address the increasing problem of bacterial resistance to existing marketed products. This study reviews the historical basis for the current regulatory climate including the various crises that have led to considerable political pressures on the agency. Recent efforts to resolve development uncertainties and to provide economic incentives for future antimicrobial drug development are presented." @default.
• W2022657122 created "2016-06-24" @default.
• W2022657122 creator A5050331950 @default.
• W2022657122 date "2012-11-01" @default.
• W2022657122 modified "2023-10-16" @default.
• W2022657122 title "A long and winding road; evolution of antimicrobial drug development – crisis management" @default.
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• W2022657122 doi "https://doi.org/10.1586/eri.12.131" @default.
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