Former Centers for Medicare & Medicaid Services Chief Medical Officer Sean Tunis joins policy think tank Health Technology Center as a research fellow. Tunis most recently worked in the Agency for Healthcare Research & Quality's Office of Extramural Research, Education & Priority Populations (1"The Pink Sheet" Sept. 26, 2005, In Brief). Tunis left CMS in June after he accepted a fine and one-year suspension of his medical license to resolve charges that he falsified continuing medical education documents. Although HTC is based in San Francisco, Tunis will remain in Baltimore and hopes to resume practicing emergency medicine once his license is restored in 2006...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
