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.’
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
