The Development Safety Update Report (DSUR) 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. The main focus of the DSUR is data and findings from interventional clinical trials of drugs and biologicals that are under investigation, whether or not they have a marketing approval. Because clinical development of a drug frequently continues following marketing approval, 5 relevant information from post-marketing studies should also be included in the DSUR. The DSUR should concentrate primarily on the investigational drug, providing information on comparators only where relevant to the safety of trial subjects. ICH E2F