Agency concludes use of heart symbol in labeling of Rexall Sundown's CoQ-10 Ultimate softgels, Twinlab's Twinsorb CoQ10 softgels is acceptable because labeling contains "contextual statements that...establish the products are not intended to treat, prevent, mitigate, diagnose or cure heart disease." In April 23 letter to law firm Arnall Golden Gregory (Atlanta), FDA notes "if a label contains adequate context to make clear that a product" is not a disease claim, then it can be considered a structure/function claim within the scope of DSHEA. Agency's letter responds to a March 18 correspondence from AGG claiming use of the heart symbol makes products unapproved new 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.’
Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.
Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
