FDA Pushes Final Generic Labeling Rule To July

By Dani Kass (December 3, 2015, 6:48 PM EST) -- The U.S. Food and Drug Administration has pushed back to July the release of a final rule allowing generic-drug makers to update safety labels detailing new risks without agency approval. 

In December 2014, the agency had said the rule would be finalized by September 2015, according to the nonprofit Public Citizen, who said their 2011 petition led to the proposed rule. The Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, introduced in 2013, would make it easier for generic-drug makers to update labels with new safety information, according to the FDA's website.

Brand-name drugmakers can change their labels...

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