Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution
FDA Law Blog
MAY 26, 2025
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. 116(e) (emphasis added). See 21 U.S.C.
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