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Assessing the Compliance and Timeliness of Results Reporting for Clinical Trials on Antimicrobial Agents

2025-12-31 health policy Title + abstract only
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ObjectiveAntimicrobial resistance (AMR) is an urgent global health threat, resulting in more than 5 million deaths globally in 2019. Timely and complete antimicrobial agent (AMA) clinical trial results reporting is essential to evaluate the safety and efficacy of investigational therapies. The Food and Drug Administration Amendments Act (FDAAA) of 2007 mandated results reporting for applicable clinical trials to ClinicalTrials.gov. After nearly ten years of underreporting, the HHS issued the Fin...

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