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After submission to the U.S. Food and Drug Administration through MedWatch, reports enter the FDA Adverse Event Reporting System (FAERS). Here’s what happens next: • Safety reviewers analyze reports for emerging patterns • Signals are evaluated for plausibility and frequency • Manufacturers may be required to investigate further • Label updates may occur • Boxed warnings may be added • Risk mitigation programs may be implemented • In rare cases, products may be withdrawn One report rarely change
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