Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Revising ANDA Labeling Following Revision of the RLD Labeling." This guidance provides recommendations for updating labeling for abbreviated new drug applications (ANDAs) following revisions to the labeling of a reference listed drug (RLD), including information on how to identify RLD labeling updates and how to submit labeling updates to both unapproved and approved ANDAs to conform to RLD labeling updates. This guidance finalizes the draft guidance for industry of the same title issued on January 27, 2022.
Abstract as published in the Federal Register.
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