AAM Commends FDA For Shelving Proposed Rule On Generic Labelling

 
• By Dean Rudge

An FDA rule proposed more than five years ago that would have allowed generic sponsors to independently update their drug labels with new information has been withdrawn. In doing so, the agency conceded the potential for “significant new burdens and liabilities” for manufacturers.

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FDA pulls proposed rule that would have let Generics players update labels independently • Source: Shutterstock

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