- Does FDA receive, evaluate and store adverse events from clinical trials in the AERS database?
AERS contains adverse events for marketed products; it is not designed to track adverse events that occur during premarket clinical trials. Currently, there is no equivalent database for pre-market adverse events. Adverse events found during premarket clinical trials are reviewed as part of each new drug application. When the company submits its application for approval, it has to tabulate every adverse event for each indication.
AERS does contain some reports from clinical trials that are conducted after a drug is approved. Our postmarket safety reporting regulations refer to these as "postmarketing study" reports. Adverse event reports from postmarket studies must be submitted to FDA within 15 days if they are serious, unexpected and there is a reasonable possibility that the drug caused the adverse experience. The criterion, "reasonable possibility that the drug caused the adverse experience," only applies to these "postmarketing study" reports; other types of postmarket adverse event reports must be reported without regard to causal relationship.