A California appellate court in Los Angeles sides with a class action certification attempt on appeal against GNC about steroid-containing supplements. The court's Jan. 21 1decision reverses a lower court's rejection of plaintiff Diego Martinez's class certification attempt. The previous rejection was based on an erroneous legal assumption - "that common issues did not predominate because class members would be required to individually litigate issues of causation and injury." Martinez attempted to certify a class of anyone who purchased products from GNC containing androstenediol in California between 2000 and 2004. He alleged damages based on GNC's deceptive conduct. GNC said it ceased selling so-called supplements with androstenediol, a schedule III controlled substance, in March 2004 (2"The Tan Sheet" Oct. 27, 2003)
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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 US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.
