FDA issues generic drug guidance revisions

Yesterday, the US Food and Drug Administration (FDA) published the following guidances for Abbreviated New Drug Applications (ANDAs) for the generic medicines industry:

Final Guidance for Industry:  Revising ANDA Labeling Following Revision of the RLD Labeling

This guidance finalizes the previous version issued in January 2022 and includes minor revisions to improve clarity. The guidance provides recommendations for updating labeling for abbreviated new drug applications (ANDAs) following approved revisions to the labeling of a reference listed drug (RLD).