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Purpose To describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of biopharmaceuticals. Methods A cross-sectional analysis was performed of follow-up requirements of PSURs submitted for centrally approved biopharmaceuticals in the European Union between 1 July 2008 and 30 June 2010. A follow-up analysis on a subset of products that submitted multiple PSURs within the...
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