FDA-Approved Labeling: Is Enough Enough?
FDA Law Blog
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. According to FDA, therefore, use in pregnant women is neither condoned nor directed by the labeling—that’s a question for them to discuss with their doctors.
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