Issue Date: August 23, 2011
Issued by: Center for Biologics Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final
E2F Development Safety Update Report
The development safety update report (DSUR) proposed in this guidance is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. U.S. and European Union (EU) regulators consider that the DSUR, submitted annually, would meet national and regional requirements currently met by the U.S. investigational new drug application (IND) annual report and the EU annual safety report, respectively, and can therefore take the place of these existing reports. This guidance defines the recommended content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.
Download the Guidance Document
