DSUR (Development Safety Update Report)

A Development Safety Update Report (DSUR) is a comprehensive annual report that drug developers prepare to inform regulatory authorities about the safety of a new medicine during its clinical trial phase. It summarizes safety data collected from trials, highlights any new risks or side effects, and discusses how these are being managed. The purpose is to ensure ongoing patient safety, provide regulators with current information, and support decisions about continuing development. Essentially, the DSUR keeps regulators up-to-date on the safety profile of the investigational drug as it progresses through testing.