From Quartz.
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The FDA issued a warning letter to Novo Nordisk after a Jan. 13āFeb. 7, 2025 inspection found systemic failures in required adverse event reporting. The FDA warning letter detailed cases involving semaglutide, the active ingredient in Ozempic and Wegovy. Inspectors said Novo Nordisk missed 15āday deadlines and improperly rejected or invalidated reports, conflicting with federal rules. Examples included a death not yet reported, a disabling stroke, and a userās suicidal thoughts left under review for two months. Procedures allowed reporters to dismiss events as unrelated, and cases were invalidated despite identifiers in source records. The company has 15 business days to outline corrective actions and said the notice does not question safety or quality of its treatments, including semaglutide, liraglutide, nedosiran sodium, and estradiol. #fda #novonordisk #drugsafety #semaglutide #regulatorycompliance
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