Jones v. Premo

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• reversing a lower court and holding that a new article based on old data did not constitute “newly acquired information”
• manufacturer changed drug label to add warning under CBE regulation and FDA ordered manufacturer to remove the warning
• “The preemption analysis asks only whether GSK could have added the adult- suicidality warning through the CBE regulation, . . . not whether GSK could have persuaded the FDA after already asking four times to include that warning and being told no four times.”

Source: CourtListener parenthetical corpus (CC0).