The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence's "The Gray Sheet."
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The $13 billion total joint market is facing a number of challenges coming off the recent recession. Although the demographics related to joint replacement remain strong, manufacturers continue to be plagued by downward pressure on implant prices, a slowdown in procedure volumes, and an ongoing shift in hospital purchasing. Many believe that J&J's recent acquisition of Synthes will spark a wave of consolidation in the industry.
FDA Panel Will Have To Weigh Pediatric Cancer Drug’s ‘Higher Level’ Of Uncertainty Against Rare, Devastating Disease
US WorldMeds NDA package for eflornithine for high-risk neuroblastoma provides “a higher level of uncertainty than is typically seen in oncology applications,” agency says. Though FDA seems largely satisfied with the sponsor’s externally controlled study, confirmatory evidence may be lacking.