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Evidence Supporting EMA Drug Approvals (2020-2023): A Cross-Sectional Study of Trial Design and Outcomes
2026-02-05
health policy
Title + abstract only
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BackgroundThe strength and transparency of clinical trial evidence supporting drug approvals has become increasingly scrutinized, particularly considering the increased use of regulatory flexibility and expedited pathways. While U.S. Food and Drug Administration (FDA) standards have been extensively analyzed, evidence standards at the European Medicines Agency (EMA) remain less well-characterized. Thus, this study aims to systematically assess the design, quality, and outcomes of pivotal efficac...
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