A case in which the Court held that “clear evidence” that the FDA would not have approved a change to a drug’s label—thus pre-empting a state-law failure-to-warn claim—is evidence showing that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning. The Court further held that the question of agency disapproval is primarily one of law for a judge, not a jury, to decide.