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.’
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
