Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; Final Guidance for Industry; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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 This guidance finalizes the draft guidance for industry of the same title issued on January 27, 2022.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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