FDA requests industry help to interpret a provision in the FDA Amendments Act of 2007 that could block the sale of new and some existing dietary supplements and food ingredients if read strictly. A provision of FDAAA amended the Food, Drug and Cosmetics Act to prohibit the sale of any drug or biological product for which "substantial clinical investigations" were conducted and publicized, and any food product to which an approved drug or licensed biological has been added (1"The Tan Sheet" March 10, 2008, p. 3). In a July 29 Federal Register notice, the agency asks industry how to interpret clinical investigations and how the provision will impact supplements and self-determined GRAS status. The amendment has no legislative history or grandfather clause for existing products. FDA also seeks comments on whether the provision is a disincentive to study conventional foods and dietary supplements and, if so, how to minimize that impact. Comments are due by Oct. 27...
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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.’
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Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
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