Six top industry insiders recently shared with "The Tan Sheet" their thoughts on the pending release of FDA's final rule on dietary supplement Good Manufacturing Practices. The participants were: Scott Bass of the law firm Sidley Austin Brown & Wood; Council for Responsible Nutrition President Annette Dickinson, PhD; Utah Natural Products Alliance Executive Director Loren Israelsen; American Herbal Products Association President Michael McGuffin; U.S. Pharmacopeia Director-Dietary Supplements David Roll, PhD; and National Nutritional Foods Association Executive Director & CEO David Seckman.
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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 the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
