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Revisions for generic drug labeling

This article was originally published in The Tan Sheet

Executive Summary

Generic drug manufacturers will be responsible for monitoring any labeling changes for the reference listed drug for application to their own products, FDA says in a guidance on "Revising ANDA Labeling Following Revision of the RLD Label." The guidance asks ANDA sponsors to routinely monitor the Office of Generic Drugs' Labeling Review Branch Internet homepage, which will provide monthly updates of approved labeling changes for reference listed drugs with approved ANDAs. Previously, OGD notified ANDA sponsors when the approved labeling for an RLD had changed. The office will continue to notify generic firms in the case of labeling revisions connected with a "Dear Doctor" letter or other situations requiring immediate widespread professional notification

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