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.’
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
