From a regulatory point of view, an unexpected adverse event is any adverse event that is not listed in the current labeling for the medicine.
When the company receives a report that meets these criteria, it is required to send it to FDA within 15 days. The company is required to follow-up and inform FDA of whatever it learns within 15 days.
Companies are required to submit non-expedited adverse event reports in periodic safety reports. They are required to submit these other reports only from domestic sources. These reports include events that are serious and expected, or non-serious.
These reports are submitted quarterly for 3 years from the approval date; after 3 years, the reports are submitted annually. Periodic safety reports include narrative summaries, analyses, tabulations and a history of actions taken because of adverse events.
FDA regulations require companies to use the periodic adverse drug experience report for drugs and the periodic adverse experience report for biologics, to report events related to approved products. The Periodic Safety Update Report (PSUR) is the ICH document. If requested, FDA will give companies permission to use the PSUR submission format.