Adverse Effects and Toxicology Practice Test

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What is the name of the public database containing adverse events that have been reported to the FDA?

FDA Adverse Event Monitoring System (FAEMS)

Postmarketing safety surveillance relies on a central public database that stores adverse events reported to the FDA. The correct name for that database is the FDA Adverse Event Reporting System, abbreviated FAERS. It collects reports from manufacturers, healthcare professionals, and the public, often submitted via the MedWatch safety program, and is used to monitor drug safety and detect signals. The other names listed aren’t the official database used for FDA adverse event reporting, so FAERS is the standard reference you’ll see in regulatory and pharmacovigilance contexts.

FDA Adverse Event Reporting System (FAERS)

MedWatch Adverse Event Registry

Global Adverse Event Database

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