"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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A new pilot aims to take Brazil closer to ‘digital transformation.’
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
