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 EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.
Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.
