FDA "shall not proceed" with its ephedra rulemaking "without using sound science to assure strict compliance with the Dietary Supplement Health & Education Act" and without using adverse events reports in a "manner consistent with previous rulemakings and agency policy," a House budget bill amendment states. The amendment was offered by Rep. Sam Farr (D-Calif.) at the House Appropriations/ Agriculture Subcommittee's May 13 mark-up of the Agriculture appropriations bill. The full committee is tentatively scheduled to mark up the bill May 19.
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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.
