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Statement: FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety

View FDA’s response to the petition (PDF).

View Statement.

The Food and Drug Administration (FDA) today issued a proposed rule to revise regulations on generic drug labeling, responding to 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.