Califf Puts Weight Behind 'Sentinel' As Evidence-Generation System Of The Future
This article was originally published in Clinica
US FDA Commissioner Robert Califf senses growing support from industry for the Sentinel system for tracking postmarket product performance using insurance claims and other data that is currently applied to pharmaceuticals, and is now moving into the device arena.
You may also be interested in...
UK start-up Iceni Diagnostics has secured funding to develop its test for the live, intact SARS-CoV-2 virus and the UK government is evaluating a lateral flow device based on the technology for testing saliva samples as part of efforts to step up rapid testing in the country. See what Iceni’s CEO Rob Field said about it here.
The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.
Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.