OTC drug interaction labeling: FDA Oct. 4 Federal Register notice would permit labeling to shorten the format for interaction warnings. The current required drug interaction precaution begins with the statement "Drug interaction precaution" followed by "Do not use this product." Under the proposed format, the words "`Drug interaction precaution' would no longer be needed and the precaution would begin with `Do not use with' and could be followed by `a prescription drug for....'" FDA says that "this approach would shorten the required labeling without changing the meaning," the agency notes. Written comments on the proposed rule are due by Jan. 2. The proposed modification would serve as an additional alternative to interchangeable terms previously suggested by the agency in August 1994 ("The Tan Sheet" Aug. 8, 1994, p. 7)...
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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.
