EPHEDRINE WITHDRAWAL FROM OTC STATUS PROPOSED BY FDA in a July 27 Federal Register notice. FDA said the notice of proposed rulemaking was issued "in response to a request from the U.S. Department of Justice's Drug Enforcement Administration to restrict OTC availability of ephedrine" because of its use in the illicit manufacturing of controlled substances such as methamphetamine and methcathinone, and due to the potential for misuse and abuse of OTC ephedrine drug products.
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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.’
Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.
Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!
The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.
