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Development safety update report (DSUR)
Development safety update report (DSUR)
Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU). In 2011, the US FDA adopted the International Council on Harmonization (ICH)’s guidance, the E2F DSUR, and began accepting the DSUR in place of the IND annual report.