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database tracking drug and biologic safety issues post-marketing

The FDA Adverse Event Reporting System (FAERS) is a database managed by the U.S. Food and Drug Administration that collects information on adverse events and medication errors reported by healthcare professionals, consumers, and manufacturers. This system helps the FDA monitor the safety of drugs and biologics after they are marketed, ensuring that any potential risks are identified and managed appropriately.

Related Terms

• Pharmacovigilance
• MedWatch
• Drug Safety Monitoring
• FDA approval
• FDA registration
• FDA-approved
• Food and Drug Administration
• Regulatory Approval
• Off-label Use
• Drug Approval Process