E2F: Development Safety Update Report

Regulatory Resource: E2F: Development Safety Update Report

Description:

This guideline has been released for consultation under Step 2 of the ICH process on 5 June 2008.
The main focus of the DSUR is data from interventional clinical trials (referred to in this document as "clinical trials") of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors.

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