What the post-market record is reporting.
Aggregate adverse-event volumes and the most-reported terms across FDA’s post-market systems — drug (FAERS), device (MAUDE), food (CAERS), and veterinary — the pharmacovigilance signal that shows where harm is being reported across every regulated industry.
Adverse-event reporting is the post-market half of the quality system. SPEQ reads these signals through two maturity lenses: Pharmacovigilance (GVP)— the maturity of a firm’s signal detection and reporting — and Data Integrity, because a report is only as trustworthy as the record behind it. High volumes are a function of both real events and reporting completeness, so counts compare reporting activity, not risk.
Data: U.S. FDA openFDA event APIs (FAERS, MAUDE, CAERS, animal & veterinary), aggregate counts only over the rolling 12 months — no individual case records are stored or shown. Reported terms and volumes reflect reporting activity and completeness, not confirmed causation or comparative risk. The GVP / Data-Integrity framing is a SPEQ interpretation.