NLEA LABELING REQUIREMENT EXEMPTION FOR SMALL BUSINESSES may apply to dietary supplement manufacturers, packers or distributors with total annual retail sales below $500,000 or supplement sales below $50,000 a year, according to a proposed rule published in the March 14 Federal Register. However, products must not make any nutrition claims or bear any nutrition information "in any context on the label or in labeling or advertising," the proposal states.
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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.’
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
