Mini Sentinel Data Covers 126 Million Patients; FDA Weighing Potential Uses For Drug Industry
This article was originally published in The Pink Sheet Daily
Executive Summary
With the recent addition of claims data from two major insurance companies, the FDA postmarketing drug safety surveillance pilot project known as Mini Sentinel has already exceeded its statutory goal of gaining access to electronic health care data for 100 million individuals by July 12, 2012.
You may also be interested in...
PDUFA V: Sentinel, Regulatory Science Upgrades Could Gain User Fee Funding
FDA’s Sentinel Initiative appears to be gaining support through the Prescription Drug User Fee Act, although industry is not interested in blindly pumping user fee revenue into the project.
"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
Lecanemab Data On Benefit In Alzheimer’s Might Satisfy FDA – But What About Medicare?
Centers for Medicare and Medicaid Services’ standard for determining whether drugs produce a clinically meaningful improvement in cognition that would allow for broader Medicare coverage is unclear. But Eisai/Biogen’s lecanemab is likely to serve as a first test.