The US Food and Drug Administration (FDA) launched [removed]a new Web site[/removed] to accommodate information regarding its Sentinel Initiative. The new Web site contains a review of technical methods used to create search functions for finding safety events. Visitors to the site can subscribe to receive updates when information is available.
The Sentinel Initiative was launched in May 2008 to increase the FDA’s ability to track the safety of drugs, biologics, medical devices, and ultimately, all FDA-regulated products once they reach market. The national electronic system will complement existing systems that the FDA has in place to track reports of adverse events linked to the use of its regulated products.
Pilot projects have been conducted addressing technical and policy issues involving the development of the system, from data standards to privacy and security.
The Agency plans to monitor health care safety issues in real time through the sentinel system. The FDA eventually wants to electronically link data from several sources about medication and other FDA-approved products to assess their safety.
