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FDA’s Adverse Event Reporting System Consolidation Promises Efficiency but Raises Concerns Over Data Accessibility and Potential Misuse
The U.S. Food and Drug Administration (FDA) is undertaking a significant modernization initiative by consolidating its disparate adverse event reporting systems into a single, unified platform, the FDA Adverse Event Monitoring System (AEMS). While the agency asserts this move is designed to enhance operational efficiency, reduce costs, and improve post-market surveillance, some industry experts and…
