The American Herbal Products Association encourages FDA to implement carefully Sec. 912 of the FDA Amendments Act so it does not discourage investigations of the safety, functional effects or health benefits of substances that may be added to foods, the trade group says in comments submitted Nov. 25. FDAAA Sec. 912 prohibits interstate commerce of foods with an added approved drug or licensed biological product which is the subject of publicly disclosed substantial clinical investigations. If read strictly, this provision could block the sale of new and some existing dietary supplements and food ingredients, experts warn (1"The Tan Sheet" Aug. 11, 2008, In Brief). However, AHPA argues that the section does not replace or amend the Dietary Supplement Health and Education Act and does not affect dietary supplements
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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.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
