Proposed FDA Rule Could Bring Failure-To-Warn Liability

Law360, New York (January 23, 2014, 1:36 AM EST) -- A rule proposed by the U.S. Food and Drug Administration in early November could increase generic drug manufacturers' exposure to legal liability. Specifically, the FDA is proposing to amend 21 C.F.R. part 314 — Applications for FDA Approval to Market a New Drug, in order to allow generic drug manufacturers to update labels independently from brand-name manufacturers. According to the FDA, this rule would operate to permit generic drug manufacturers to update drug labels themselves when they acquire new information about a drug and submit a "changes being effected" ("CBE") supplement for the FDA's review. Under the current rule, only brand-name manufacturers can update labels and submit CBE supplements....

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