Fda Periodic Safety Update Reports

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. The 120 Day Safety Update contains any new safety information learned about the drug that may reasonably affect the statement of contraindications, warnings, precautions, and adverser reactions in the draft drug labelling. Also know as the Safety Update Report, the report must be received by the FDA within 120 days of drug approval submission. Follow-up information to adverse drug experiences submitted in a periodic report may be submitted in the next periodic report. As regulated by the FDA, organizations need to submit these reports once in a quarter for three years within 30 days of close of quarter and later should submit these reports annually within 60 days of US approval date. Periodic Adverse Drug Experience Reports (PADERS): NDA Periodic Reports and Periodic Safety Update Reports (PSURs) M ost countries now accept and usually require the submission of Periodic Safety Reports for aggregate postmarketing safety reporting. FDA accepts all three formats, the PADER/PAER, PSUR, and PBRER, to fulfill the postmarketing periodic safety reporting requirements under §§314.80(c)(2) and 600.80(c)(2). Each format must be.

Periodic Safety Update Report Example

Periodic Safety Update Report Psur

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.

Submit Comments

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
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All written comments should be identified with this document's docket number: FDA-2008-D-0386.

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