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.’
Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?
Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."
The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.
