- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2008-D-0386.