Elimination of the 180-day "first generic" exclusivity provision in the Waxman/Hatch Act may not be harmful to competition, Federal Trade Commission Bureau of Competition Assistant Director for Policy & Evaluation David Balto told the Food & Drug Law Institute annual meeting in Washington, D.C. Dec. 17.
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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.’
A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.
The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.
The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.
