DSUR - What does DSUR stand for? The Free Dictionary
References in periodicals archive
Their consistent updating of mainly DSURs
and RMPs over the past years has laid the groundwork for the application of new templates and guidelines which have now become a regulatory requirement.
The development safety update report (DSUR
); harmonizing the format and content for periodic safety report during clinical trials.
In August 2011, the FDA released a new guidance concerning the Development Safety Update Report (DSUR
) which regulators are accepting in place of the previously required Investigational Annual Report submitted to the FDA and the EU Annual Safety Report submitted to the EU annually.