The Colgate brand marketer expects its European business to grow about 5.5 percent organically in 2010, Colgate Europe President Alec de Guillenchmidt said during the Deutsche Bank Global Consumer Conference in Paris June 16. He indicated oral care is the largest growing segment of its European portfolio, having grown from 32 percent of its portfolio in 2000 to 46 percent in 2009. In 2009, the oral, personal and home care divisions in Europe delivered $2.8 billion, he added
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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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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.