Testosterone precursor under investigation by the Drug Enforcement Administration for possible regulation under the Anabolic Steroids Control Act. A May 10 letter to DEA from Office of National Drug Control Policy Director Barry McCaffrey cites studies by the Swedish Board of Customs and the Canadian Doping Control Lab that find several "andro" products actually contain pure testosterone. To be regulated as a steroid, a product must be chemically related to testosterone, pharmacologically related to testosterone and promote muscle growth. In a separate May 10 letter to FTC requesting investigation, McCaffrey says if testosterone content in supplements is confirmed, "a number of these products are seriously mislabeled" and "contain controlled substances." McCaffrey notes industry reports that use of andro has jumped "five-fold" in the wake of baseball great Mark McGuire's "disclosure" of his use of the substance
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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.’
While Japanese government announces 8-15% price cuts for four drugs, including Leqembi, industry groups urge operational improvements to national cost effectiveness assessment scheme.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
