FDAが統一有害事象モニタリングシステム（AEMS）を開始
On March 11, 2026, the U.S. Food and Drug Administration (FDA) officially announced the launch of the Adverse Event Monitoring System (AEMS). This brand-new unified platform and interactive public data dashboard is designed to analyze and process adverse event reports with greater efficiency. The system is scheduled to be fully operational by the end of May 2026. This transition will bring significant changes to the industry landscape and the way the public accesses data. Here is the core information you need to know: A “Unified” Era: Covering All Regulated Products The launch of AEMS marks a major milestone in the FDA’s data integration efforts. It will provide real-time adverse event reporting across all FDA-regulated product categories, including: Retiring Legacy Systems To achieve this integration, the FDA will decommission several aging, decentralized reporting systems across various centers. The new AEMS will directly replace the following well-known platforms: By consolidating these systems […]
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