2007 Healthcare Manufacturing Medical 
FDA Law
AUGUST 21, 2023
Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.
FDA Law
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. 118, 129 (2007) (quoting Abbott Labs v. MedImmune, Inc.
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