The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023
Drug & Device Law
DECEMBER 29, 2023
Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.
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