Tainted "supplement" recalls soar: Products marketed as dietary supplements but containing active pharmaceutical ingredients were the subject of 80 class I recalls through the first three quarters of fiscal 2010 - compared to slightly more than 50 in 2009 and 10 in each of 2008 and 2007. Adulterated supplements are "blowing this off the chart," says Mike Smedley, deputy director of FDA's Division of Manufacturing Product Quality in the drug center's Office of Compliance. Rx and OTC pharmaceuticals together have totaled fewer than 20 class I recalls in 2010, said Smedley, speaking at the Consumer Healthcare Products Association's Manufacturing Controls Seminar Oct. 13-14 in New Brunswick, N.J. A class I recall is the most serious, denoting a product has potential to cause adverse health effects or death. Smedley said DMPQ recently established a data analysis team to identify root causes of recalls that may trend across multiple firms. FDA has prioritized enforcement against adulterated supplements, which often are marketed for weight loss, strength training or sexual enhancement (1"The Tan Sheet" June 21, 2010)
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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.’
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
