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Sentinel Initiative

Meaning

The Sentinel Initiative is a comprehensive, national electronic system established by the U.S. Food and Drug Administration (FDA) to proactively monitor the safety of regulated medical products, including drugs, biologics, and medical devices, after they have been approved and marketed. In the context of hormonal health, this initiative is crucial for continuously assessing the real-world safety and effectiveness profiles of hormone replacement therapies, oral contraceptives, and other endocrine-modulating agents. It represents a vital post-market surveillance tool for clinical practice.