FDA Mulls Dramatic Shift In Generic-Drug Labeling Regs

Law360, New York (February 11, 2013, 6:02 PM EST) -- The U.S. Food and Drug Administration is considering allowing generic-drug makers to change a product's safety warning, the agency confirmed Monday, a move that would dismantle the requirement that labeling for generic drugs follow that of their brand-name counterparts.

The U.S. Department of Justice indicated the FDA was mulling such a move in a footnote in an amicus curiae brief it filed with the Supreme Court in January. The brief supported Mutual Pharmaceutical Co. Inc. in its appeal of a First Circuit decision that found design...
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