Regulatory News In Brief
This article was originally published in The Tan Sheet
Executive Summary
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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Alli Labels In U.S. Add Seizure Advisory Similar To E.U. Change
GSK also recently posted to the alli brand website statements on why language was added to the Drug Facts panel for the orlistat 60 mg product. FDA contacted Glaxo in November 2013 requesting a supplement NDA for the label change, FDA’s Division of Nonprescription Clinical Evaluation said.
Alli Labels In U.S. Add Seizure Advisory Similar To E.U. Change
GSK also recently posted to the alli brand website statements on why language was added to the Drug Facts panel for the orlistat 60 mg product. FDA contacted Glaxo in November 2013 requesting a supplement NDA for the label change, FDA’s Division of Nonprescription Clinical Evaluation said.
Regulatory News In Brief
Far Ocean Group in deep with FDA; Keystone Labs topicals in violation, according to warning letter; NAD nixes Alde’s antifungal nail polish claim; FDA supplement marketing notice e-submissions in the works; South Korea reorganizes, strengthens its Ministry of Food and Drug Safety.