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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Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.