Federal law preempts state -law tort claims where a brand- name drug's manufacturer provides the FDA with all material information in its possession at the time the FDA resolves the manufacturer's label change request , or whether applicants must also provide the FDA with data and information t hat does not exist or that, under binding regulations, the FDA does not want and that the FDA did not rely upon in reaching its decision.

Whether federal law preempts state-law tort claims where a brand-name drug's manufacturer provides the FDA with all material information in its possession at the time the FDA resolves the manufacturer's label change request, or whether applicants must also provide the FDA with data and information that does not exist or that, under binding regulations, the FDA does not want and that the FDA did not rely upon in reaching its decision