How many adverse event reports does FDA receive a year, and why does that volume matter?

FDA has reported receiving more than two million adverse event and medication error reports a year for drugs and biologics, now held in its Adverse Event Monitoring System (AEMS), formerly FAERS. Each report is an individual case that is coded to MedDRA and assessed for seriousness, expectedness and causality. At that volume, structure at intake decides how much of the work is review and how much is reconstruction. Burna AI produces that structure for every trial adverse event: a CTCAE grade, a MedDRA LLT code, an attribution score for each drug and the source line behind each, signed by an investigator. Postmarket case processing is the next lane for the same engine, so a signal after approval can be read against the trial record behind the label.