Regulatory News In Brief
This article was originally published in The Tan Sheet
FDA warns about supplement GMP violations; ERSP asks Lunada to pull Amberen claims; supplement disease claims axed in U.K.; Herbalife recalls mislabeled mixes; authentic and counterfeit Maxiloss Weight Advanced on recall; MHRA warns of poison Chinese medicines.
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Appropriations subcommittee largely ignores FDA; analysts predict lower Novartis OTC sales; France tightens advertising rules; NAD weighs in on Lunada claims; Global Biotechnologies supplements seized; Tetley tea faces lawsuit for antioxidant claims; more news In Brief.
ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.
Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).