FDA Reopens Comment Period for Drug Labeling Rule

FDA Reopens Comment Period for Drug Labeling Rule

The FDA has reopened the comment period for its proposed rule that would allow generic drug manufacturers to unilaterally update their warning labels.  The proposed rule would change the result in the Supreme Court’s Pliva v. Mensing decision, which held that certain failure to warn claims against generic drug manufacturers are preempted, while those same claims against brand-name drugs are not.  Interested parties have until April 27th to weigh in on the consequences of this rule and make suggestions for how the rule could be improved. [3/4/15]

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