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Home » FDA Backs Solicitor General in Generic Preemption Cases
FDA Backs Solicitor General in Generic Preemption Cases
November 23, 2010
Federal regulations do not categorically preempt a plaintiff’s “failure-to-warn” claims against generic-drug makers, because manufacturers are obligated to inform the FDA of risks that may warrant a labeling change, the agency says in an amicus brief filed this month with the U.S. Court of Appeals for the Sixth Circuit.