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These warning letters are the result of ongoing monitoring by the FDA of various surveillance systems, including reviewing various data to identify emerging products that may be appealing to or popular among adolescents

Revised: 12/2025 Full Prescribing Information WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1)]

Seventh, FDA has yet to take any enforcement actions against products with pending PMTAs, even though they have no more legal right to be on the market than products that have never filed a PMTA

"In Profane Rant, Melania Trump Takes Aim at Migrant Children and Critics"