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FDA Guidance On ANDA Label Updates, Submissions Finalized

 
• By Malcolm Spicer

CDER says document “provides clear expectations for when updates to labeling are required, the process for updating labeling, and the types of submissions for labeling updates.”

• Source: Shutterstock

The US Food and Drug Administration’s final guidance on revising labeling for generics of OTC and Rx drugs following revisions to reference list drugs’ labeling includes recommendations on monitoring originator updates and other considerations for submitting an update.

Those other considerations include submitting labeling updates for both unapproved and approved abbreviated new drug applications to conform to labeling...

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