EPHEDRINE ALKALOID PER-SERVING LIMIT OF 8 MG SUGGESTED BY FDA in a proposed rule published in the June 4 Federal Register. The rule is directed at dietary supplement products containing ephedrine alkaloids derived from raw botanicals -- products usually labeled as containing "ephedra," "Chinese ephedra" or "ma huang" that are sold for weight loss, increased energy and body building. The proposal does not apply to OTC drugs.
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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.’
Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion
Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
