FDA is "toying around with the idea of coming up with [an OTC] label" similar to the one devised for foods and dietary supplements under the Nutrition Labeling & Education Act, OTC Monograph Review Staff Director William Gilbertson told a Society of Cosmetic Chemists symposium in Orlando, Fla. on Oct. 3. Gilbertson pointed out that although "you wouldn't be able to get all the drug inforamtion in that box, ... you could get the essential information in and that could be supplemented by other labeling." He noted that the idea for a standardized facts box came up during a recent meeting with FDA Commissioner David Kessler "about ways to deal with diet pills".
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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 UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
