OTC Packaging Should Fit Labeling, FDA's Ganley Says
• By The Tan Sheet
OTC manufacturers should tailor product packaging to fit the labeling required under FDA's final rule rather than "chop away at the labeling rule to make it fit onto the package," Division of OTC Drugs Director Charles Ganley, MD, told industry reps at a working group meeting in Rockville, Md. Nov. 23.
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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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While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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