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GUIDANCE DOCUMENT

E2F Development Safety Update Report August 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2008-D-0386
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center 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.
 

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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:

Dockets Management
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.

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