European CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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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.
Members of Italian industry body Confindustria Dispositivi Medici should insert a suitable transparency clause in their agreements with health care professionals, says law firm Osborne Clarke, after the trade association introduced a new requirement relating to payments to HPCs.