Califf Puts Weight Behind 'Sentinel' As Evidence-Generation System Of The Future
This article was originally published in The Gray Sheet
Executive Summary
Industry is increasingly supporting the "Sentinel" system for tracking postmarket product performance with claims and other real-world tools. But more companies need to be convinced of the value of the effort in advancing development of next-generation products, rather than simply a tool for safety surveillance, FDA Commissioner Robert Califf told members of the Alliance for a Stronger FDA.
You may also be interested in...
Industry Urges Caution In Response To Growing Push For 'Real-World' Device Evaluation System
AdvaMed's new chief Scott Whitaker says industry doesn't want to sign onto a new "national evaluation system" for devices championed by FDA until it is convinced that the initiative will enhance, rather than hinder, premarket product development.
Negotiating Prices For Real-World Data Can Lower FDA Submission Costs, Shuren Says
A new national evaluation system for devices will provide collective bargaining power to reduce the costs of real-world data to substitute for clinical trials in company submissions.
Don't Finalize LDT Guidance, House Appropriators Tell FDA
FDA should "suspend further efforts to finalize the laboratory-developed test guidance" and instead work with Congress on a new regulatory pathway for LDTs, House appropriators told the agency in an FY 2017 spending bill, which also adds $10 million to fight the Zika virus.