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BioWorld - Saturday, December 20, 2025
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» SCOTUS mulls drug company responsibility when FDA says no to label change
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SCOTUS mulls drug company responsibility when FDA says no to label change
Jan. 8, 2019
By
Mari Serebrov
Should a jury second-guess the FDA's decisions in rejecting changes to prescription drug labeling? And just how much proof is needed to establish "clear evidence" that the FDA would have rejected a new warning for a drug label?
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