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.’
The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
