Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study
Dhodapkar MM, Shi X, Ramachandran R, Chen EM, Wallach JD, Ross JS. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study. The BMJ 2022, 379: e071752. PMID: 36198428, PMCID: PMC9533298, DOI: 10.1136/bmj-2022-071752.Peer-Reviewed Original ResearchConceptsPotential safety signalsSafety signalsSectional studyUS FoodDrug Administration Adverse Event Reporting SystemLiterature searchAdverse Event Reporting SystemSentinel InitiativeDrug Safety CommunicationsEvent Reporting SystemDrug safety signalsAdverse eventsCase seriesCase reportRegulatory actionDrug labelingSignificant associationFDA regulatory actionsComprehensive safety evaluationFAERSFDA