Background Factors Contributing to Safety Warning Discordance in the Initial Labeling of New Drugs in Japan, the United States, and the European Union

Drug labels summarize essential safety information for healthcare professionals and patients. However, studies have reported a discordance of safety information in drug labeling among countries/regions. We aimed to identify the characteristics of adverse events associated with discordant safety warn...

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Veröffentlicht in:	Clinical pharmacology and therapeutics 2024-12
Hauptverfasser:	Fukuda, Koichi, Narukawa, Mamoru
Format:	Artikel
Sprache:	eng
Online-Zugang:	Volltext
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