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.’
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
