FDA-Approved Labeling: Is Enough Enough?
FDA Law Blog
AUGUST 21, 2023
After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. FDA, in other words, directed, and continues to direct, pregnant women to a learned intermediary.
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