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Presentation at the FDA’s Public Meeting on the Proposed Rule Regarding Generic Drug Labeling

View the Presentation as a PDF.

Public Citizen strongly endorses the Food and Drug Administration’s proposed rule to revise regulations on generic drug labeling, an action requested in a 2011 Public Citizen petition. When finalized, the rule will allow generic drug manufacturers to update their products’ labeling to include recently acquired safety information without prior agency approval, which current FDA regulations do not allow them to do. The proposed rule will fill a longstanding, dangerous regulatory gap and provide added protection to the tens of millions of people who use generic drugs. An industry alternative proposal will not close this safety gap.