The Prescription Drug User Fee Act reauthorization under the FDA Modernization Act of 1997 has established a "five-year cycle" for review of the FD&C Act, Senate Labor & Human Resources Committee Health Policy Advisor Jay Hawkins told the annual Food & Drug Law Institute meeting Dec. 9 in Washington, D.C.
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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.
