"It would be inappropriate and illegal for any manufacturer of any nutritional supplement to include any unlabeled ingredient, including nandrolone," CRN says Sept. 27, responding to allegations made at the Summer Olympics about mislabeled supplements. U.S. shot putter C.J. Hunter, who did not compete in Sydney, stated his positive drug tests earlier this summer may have resulted from use of nutritional supplements. Nandrolone is an anabolic steroid banned by the International Olympic Committee. Performance-enhancing drugs are the primary focus of the newly established White House Task Force on Drug Use in Sports, formed in August and expected to release a preliminary report early next year (1"The Tan Sheet" Aug. 21, p. 3)
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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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Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.