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  5. FDA's Adverse Event Reporting System (FAERS)
  1. Surveillance: Post Drug-Approval Activities

FDA's Adverse Event Reporting System (FAERS)

The FDA Adverse Event Reporting System (FAERS) database contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded using terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

Learn more about FAERS



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