The eventual structure of any user fees that the generic industry may pay could be shaped to some degree by the makeup of the Senate's Health, Education, Labor and Pensions Committee, which would have responsibility for any user fee bills. So the presence of newly-elected Sen. Joe Manchin, D-W.Va., who has joined the panel at least for the rest of the year, is interesting.
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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.
