A student athlete may not "possess, ingest, or otherwise use" the "anabolic steroid" DHEA (dehydroepiandrosterone) or bitter orange (synephrine), under a policy adopted by the New Jersey State Interscholastic Athletic Association (NJSIAA) June 7. Caffeine or guarana - if the concentration in urine exceeds 15 µg/ml - and ephedrine (ephedra or ma huang) are also banned. Additionally prohibited are "substances that are included in the [stimulant or anabolic agent] class by their pharmacological action and/or chemical structure." The official 2006-2007 "NJSIAA Banned-Drug Classes" list notes that "many nutritional/dietary supplements contain NJSIAA banned substances," and concludes in bold type that since FDA "does not strictly regulate" the industry "the use of supplements is at the student-athlete's own risk." The policy is the result of a December 2005 executive order by former Acting Gov. Richard Codey (D). The order was issued following a state report on steroid use and prevention, which was prompted in turn by a New York State Task Force on Life & the Law report released in October (1"The Tan Sheet" Oct. 10, 2005, p. 6)...
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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.’
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
