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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ago that would have allowed generic sponsors to independently update their drug labels with new information has been withdrawn.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

The US Food and Drug Administration (FDA) has officially withdrawn its proposed rule that would allow generic drug sponsors to independently update their product labels with new safety information, acknowledging the potential for consumer and provider confusion and a rise in generic drug costs, among other challenges.

Industry association the Association for Accessible Medicines (AAM) welcomed the action, thanking FDA Commissioner Scott Gottlieb and the agency for “prioritizing consumer access to safe, high-quality, affordable generic medicines,” and...

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