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.’
A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.
