What is the Sentinel Initiative?
Sentinel Initiative is a long-term effort by the U.S. Food and Drug Administration (FDA) to create a national electronic system for monitoring medical product safety. It will strengthen FDA’s ability to track how drugs and other medical products perform once they go on the market and, ultimately, facilitate the development of tools to strengthen the agency’s ability to communicate safety information to the public. The Sentinel Initiative will include the development of a new electronic system, called the Sentinel System, that will enable FDA to gather information about medical products by posing targeted queries (consistent with strict privacy and security safeguards) of patient registry data, insurance claims data, and other large health care information databases. As the name implies, the system will help the FDA stand guard over the nation’s vast supply of medical products. The Sentinel Initiative will give FDA other, more proactive, tools to monitor the safe use of medical products
Related Questions
- What will the effect of these projects be on the medical product development process? How will the Critical Path Initiative help bring new treatments to patients?
- I have some ideas for modernizing medical product development, how can I get involved in FDAs Critical Path Initiative?
- What is the Sentinel Initiative?
