{"id":37011,"date":"2026-03-10T16:11:20","date_gmt":"2026-03-10T16:11:20","guid":{"rendered":"https:\/\/www.europesays.com\/dk\/37011\/"},"modified":"2026-03-10T16:11:20","modified_gmt":"2026-03-10T16:11:20","slug":"novo-nordisk-warned-by-fda-for-failure-to-report-drug-side-effects","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/dk\/37011\/","title":{"rendered":"Novo Nordisk warned by FDA for failure to report drug side effects"},"content":{"rendered":"

Novo Nordisk received a warning from the U.S. Food and Drug Administration for failing to report suspected incidents of side effects caused by its medicines, a step that is required by federal law.<\/p>\n

In a March 5 warning letter, the agency criticized the pharmaceutical company for various procedures that result in \u201cserious violations\u201d related to the reporting of side effects. The problems were initially discovered during an inspection<\/a> of Novo Nordisk facilities in early 2025.<\/p>\n

Although the inspection focused on compliance for a sample of products, the agency noted that \u201cbased on the nature of the inspection\u2019s findings and your written response and correspondence, we have serious concerns about the scope and impact of these violations on your entire product portfolio.\u201d<\/p>\n

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