FDA Rule Would Allow Generics Makers To Update Labels
By Gavin Broady (November 8, 2013, 1:40 PM EST) -- The U.S. Food and Drug administration on Friday proposed a major new rule that would allow generic-drug manufacturers to independently update product labels with newly discovered safety information, potentially upending recent U.S. Supreme Court rulings limiting the liability of generics makers.
The proposed change would eliminate current prohibitions preventing generics makers from revising safety information until the brand-name counterpart has received agency approval for similar changes. Generics manufacturers would now be allowed to submit a so-called "changes being effected," or CBE, supplement, which the FDA would then review and have the option of rejecting later, according to the agency.
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