Summary

A Development Safety Update Report (DSUR) is a periodic regulatory safety report used for drugs under development and for marketed products that are under further study in the ICH (International Council for Harmonisation) regions. The DSUR provides a comprehensive annual analysis of the product’s safety information, including ongoing assessment of the benefit-risk evaluation and safety profile, based on safety information collected during the reporting period. It is submitted annually to regulators (and may be submitted to the US authorities in lieu of the IND Annual Report). One DSUR should be generated for each product, and must include data for the reporting period from all ongoing and completed studies.

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Pharmacovigilance Nugget #2 Generating a DSUR - November 2017

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