Sentinel Will Start Small, FDA Tells IoM; Are Expectations Too Big?
Executive Summary
FDA plans to launch two "mini-Sentinel" pilot projects as the next steps towards building the active surveillance capability called for under the FDA Amendments Act of 2007, Sentinel Initiative Scientific Lead Judith Racoosin told a Sept. 2 Institute of Medicine meeting focused on the drug safety system post-FDAAA
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
FDA And CMS Agree To Share Data Routinely In Step Toward Parallel Reviews
A June 23 memorandum of understanding on data sharing could serve as a first step toward parallel reviews by FDA and CMS for marketing approval and Medicare coverage, according to FDA