Washington Roundup, March 2012
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s proposed comprehensive postmarket surveillance strategy, as well as updates on proposed 510(k) reforms and device user fees.
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Omaveloxolone, Reata Pharmaceuticals’s orphan drug for treating patients with Friedreich’s ataxia, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Europe does not have a pricing environment that rewards innovation which improves outcomes for patients, according to Vas Narasimhan, although Germany seems to be the best of a bad bunch.
All eyes were on the European Commission in January as it edged closer to adopting new legislation that will see the Medical Device Regulation transition deadlines extended.