Preemption Denied Where New Drug Warnings Weren't Considered By FDA
PHILADELPHIA - A Pennsylvania federal judge on Oct. 16 declined to give deference to the Food and Drug Administration's preemption rule and said a failure-to-warn claim in an Elidel case is not preempted where the FDA never considered and rejected stronger warnings (Andrea Perry, et al. v. Novartis Pharmaceuticals Corp., et al., No. 05-5350, E.D. Pa.).
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Cadence Pharma recalls one lot of Ofirmev
(Reuters) - Cadence Pharmaceuticals Inc said it recalled one lot of its injectable painkiller Ofirmev after a routine stability test revealed the presence of an unidentified particle in a vial. (Source: Reuters: Health)
