Postmarket Drug Safety Surveillance: Updates On Sentinel, OMOP Projects
Executive Summary
FDA is making progress on creating a common language that would allow for drug safety queries in disparate database sources linked to a national Sentinel network, according to FDA Office of the Commissioner Senior Policy Analyst Melissa Robb
You may also be interested in...
Sentinel Initiative's Potential Shortcomings Illuminated At Avandia Panel
The recent Avandia safety panel meeting - during which two FDA advisory committees were unswayed by the results of an observational study by one of the agency's own scientists - underscores the challenges that FDA's Sentinel Initiative will have in becoming an essential regulatory tool
Sentinel Initiative's Potential Shortcomings Illuminated At Avandia Panel
The recent Avandia safety panel meeting - during which two FDA advisory committees were unswayed by the results of an observational study by one of the agency's own scientists - underscores the challenges that FDA's Sentinel Initiative will have in becoming an essential regulatory tool
"Mini Sentinel" With Harvard Gets FDA Halfway To Health Record Target
FDA's four-year, $72 million contract with Harvard Pilgrim Health Care Inc. will create a database that eventually incorporates 60 million health records. The system will bring FDA more than halfway towards its statutory goal of being able to analyze data from 100 million patients