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Proposed CBE Rule Could Increase Generic Liability

By Mari Serebrov
Washington Editor

Monday, July 8, 2013
The FDA is working on revisions to its labeling regulations that could revoke the free pass the Supreme Court has handed generic drugmakers when it comes to state failure-to-warn claims. The proposed changes would put generic drugmakers on par with brand drugmakers in the submission of changes-being-effected (CBE) labeling supplements.

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