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FDA Pushes Back Rule On Generic-Drug Warning Labels

Law360, New York (November 18, 2014, 5:14 PM EST) -- The U.S. Food and Drug Administration on Tuesday said it doesn’t expect to finalize a proposal to let generic-drug makers unilaterally update their warning labels until late next year, a setback for plaintiffs lawyers who expect the regulation to boost product liability suits.

Previously set for release next month, the final rule on labeling changes now is scheduled for publication on Sept. 30, 2015. It’s common for regulations to take longer than expected, but the labeling rule is eagerly anticipated, as it’s likely to nullify the U.S. Supreme Court’s 2011 decision in Pliva v. Mensing and trigger an immediate legal fight...

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