Japan’s New 'Fast-Break Scheme' To Reduce Clinical Trial Burden For Medtech
Japan’s “fast-break scheme” is coming soon and will be the country’s fourth procedure for accelerating the approval of important medical devices.
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A number of new products have been submitted for review at the European Medicines Agency. While marketing authorization applications from ViiV Healthcare and BioMarin Pharmaceutical are being fast-tracked, a submission from Incyte is not.
Medtronic Wins In England’s NICE Decision On Implantable Monitors For Stroke Patients; Biotronik And Abbott Lose
UK health technology assessment body NICE says that Medtronic’s Reveal LINQ, which transmits data remotely to doctors, is likely to be a cost-effective use of National Health Service resources.
Using the QALY is expected to help the Danish Medicines Council make its decisions on the cost effectiveness of drugs more transparent, but it will also extend the time the council takes to make a recommendation.