In June, FDA launched an internal Transparency Task Force to evaluate how to make the agency's decision-making process more accessible to the public. The agency held two public meetings and solicited comments from the public; the docket closed Nov. 6. FDA Principal Deputy Commissioner Joshua Sharfstein, who chairs the task force, spoke to "The Pink Sheet" about its initial findings
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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.
