The agency recalls products marketed as sexual enhancement, weight-loss and muscle-gain supplements because of threats to consumer safety. On Nov. 9, RockHard Labs of Atlanta voluntary recalled RockHard Weekend for erectile dysfunction, which FDA said contained the undeclared ingredient sulfoaildenafil. FDA recently warned against use of Imulsaria's Stiff Nights, which it said contains the same active ingredient (1"The Tan Sheet" Nov. 9, 2009, In Brief). The agency also announced Nov. 12 that Westminster, Calif.-based GMP Herbal Products voluntarily recalls Pai You Guo, labeled as a weight-loss supplement, in which FDA found the appetite suppressant sibutramine, contained in the Rx obesity drug Meridia, and the suspected carcinogen phenolphthalein (2"The Tan Sheet" Nov. 16, 2009, In Brief). Finally, FDA said Nov. 12 that a number of products made by Oviedo, Fla.-based IDS Sports, including Bromodrol and Ripped Tabs TR, contain steroids and are recalled. Steroids sold as "supplements" is an area of particular concern within the supplement industry (3"The Tan Sheet" Oct. 26, 2009)
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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.’
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
