FDA focuses on patient safety and quality of care
Device Regulation Alert: Safety, Compliance and Reimbursement News, June 1, 2008
The FDA is starting a new program, the “Sentinel Initiative,” to identify post-market adverse events and improve patient safety and quality of care.
A white paper, titled “The Sentinel Initiative – A National Strategy for Monitoring Medical Product Safety” explains the Sentinel System, which will allow the FDA to detect problems with approved drugs and medical products such as devices earlier.
The initiative will involve cooperation from multiple private and government entities to utilize claims and medical record data. Additionally, Medicare prescription drug program claims data can be used for research, quality activities, and coordination of care. The Centers for Medicare and Medicaid Services will share prescription drug program data allowing the FDA to monitor drug safety.
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