USP GMP GUIDELINES GENERALLY ACCEPTED BY DIETARY SUPPLEMENT INDUSTRY and are already "standard practice" at many companies, USP Vitamins, Minerals and Enterals Subcommittee member Dennis Gorecki, PhD, University of Saskatchewan, noted in summarizing the industry workshops on USP good manufacturing practices standards held during a May 22-25 U.S. Pharmacopeia Open Conference in Cambridge, Mass. Gorecki noted, however, that some conference participants expressed concern that proposed revisions to "several sections" of USP's GMP standards "lead to ambiguous interpretation."
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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.’
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.
The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.
