Recent FDA advisory committees on Avandia and Ketek have featured conflicting points of view from FDA internal staff. Get ready for more public airings in the future. Influential Iowa Republican Senator Charles Grassely is directing FDA to bring all opinions into the open.
Cole Werble
The signature event for the Food & Drug Administration during the landmark "drug safety" year of 2007 occurred on July 30 when the head of one of FDA’s drug review...
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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.
