MedWatch (FDA)
The FDA's safety information and adverse event reporting programme. MedWatch collects voluntary reports from healthcare professionals and patients about serious adverse events, product quality problems, and medication errors. Reports are entered into the FDA Adverse Event Reporting System (FAERS) database.
Technical Context
MedWatch accepts reports of: suspected adverse drug reactions, product quality problems (contamination, degradation, defective devices), medication errors, and product use errors. Reports can be submitted online (www.fda.gov/medwatch), by mail, fax, or phone. FAERS (FDA Adverse Event Reporting System) stores and analyses MedWatch reports using MedDRA coding. FDA safety evaluators review reports for signals — patterns of adverse events that may indicate a previously unrecognised drug risk. Signals that pass initial evaluation trigger: information requests to manufacturers, enhanced surveillance, epidemiological studies, advisory committee meetings, and potentially label changes or market actions. The FDA Safety Reporting Portal (SRP) enables electronic submission and tracking. FAERS data are publicly available (with patient privacy protections) through the FDA's OpenFDA and FAERS Public Dashboard, enabling independent signal detection research.