We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Supports Solicitor General in Generic Preemption Case
FDA Supports Solicitor General in Generic Preemption Case
November 24, 2010
Federal regulations do not categorically preempt a plaintiff’s “failure-to-warn” claims against generic drugmakers, because manufacturers are obligated to inform the FDA of risks that may warrant a labeling change, the agency says in an amicus brief filed Nov. 16 with the U.S. Court of Appeals for the Sixth Circuit.