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.’
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
