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Sources: FDA communications and published reviews ( [17] ) ( [19] ) ( [18] ) ( [21] ) ( [22] ) ( [23] ) ( [1] ) ( [25] ) ( [27] ).) These cases highlight that once a safety signal is deemed significant, FDA acts decisively, either by imposing a box (SSRI, montelukast, CAR-T, etc.) or removing one (HRT) after review

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CrossRef Predictors of Discordance Between Controlled Attenuation Parameter and Magnetic Resonance-Proton Density Fat Fraction in Hepatic Steatosis Dong Yun Kim, Hyung-Jin Rhee, Beom Kyung Kim Clinical and Translational Gastroenterology .2026