FDA should establish a "new working group composed of scientists, agency experts, consumers, herbalists and industry to design a better system for reporting suspected adverse health events" related to dietary and herbal supplement use, Metabolife International CEO Michael Ellis states in an Aug. 11 letter to Commissioner Jane Henney, MD. Metabolife markets the ephedra weight loss product Metabolife 356; the letter comes close on the heels of the GAO report concerning FDA's proposed rule restricting the use of ephedrine alkaloids in dietary supplements (1"The Tan Sheet" Aug. 9, pp. 3-5). FDA's AER system for dietary supplements also was the subject of a House Government Reform Committee hearing May 27 (2"The Tan Sheet" May 31, pp. 3-5)
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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.
