RU-486 DECISION DEADLINE COINCIDES WITH CONGRESSIONAL DEBATE on President Clinton's veto of a ban on partial birth abortions. The confluence of FDA's publicly stated Sept. 18 deadline for a decision on the abortifacient and the Congressional attention to the veto gave political resonance to FDA's decision to grant "approvable status" to mifepristone. Following the advisory committee review of mifepristone in July, FDA Commissioner Kessler declared the agency would make a decision by the six-month user fee deadline of Sept. 18 ("The Pink Sheet" July 22, p. 3).
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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.’
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
