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FDA News In Brief

This article was originally published in The Tan Sheet

Executive Summary

Dickinson installed as permanent chief counsel; Schwabe’s Umcka homeopathics deemed new drugs for cold/flu claims; inadequate GMPs weigh on Vitagenic; more FDA In Brief.

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“Mender” Supplement Firm Hopes To Reopen After Mending Its Violations

BioAnue Labs says it temporarily stopped selling its products, which FDA warned are unapproved new drugs due to claims the firm made. BioAnue’s website and others associated with the firm continue to advertise supplements under brands that include a common disease name and terms that refer to treating the condition.

“Mender” Supplement Firm Hopes To Reopen After Mending Its Violations

BioAnue Labs says it temporarily stopped selling its products, which FDA warned are unapproved new drugs due to claims the firm made. BioAnue’s website and others associated with the firm continue to advertise supplements under brands that include a common disease name and terms that refer to treating the condition.

Regulatory News In Brief

Orlistat benefits outweigh risks, EMA says; J&J, Energizer to study SPF 85; Health Canada warns about Miracle Mineral Solution; Regencea recalls RegenArouse; more Regulatory News In Brief

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