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Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. 118, 129 (2007) (quoting Abbott Labs v. MedImmune, Inc.