FDA Punts Generic Label Rule To 2015; GPhA Resumes Bid To Quash Rule

November 26, 2014 at 1:44 PM
FDA's decision to punt to September 2015 a rule requiring generic drug companies to unilaterally update labels when new safety information emerges opens a window for generic companies to continue their fight to overturn the measure but disappoints public health advocates who view the labeling shift as a key drug safety measure. The agency on Friday (Nov. 21) quietly revealed plans to take an extra nine months to wade through comments on the controversial proposed rule, which would likely draw...


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