Revising ANDA Labeling Following Revision of the RLD Labeling

On 25 January 2022 the FDA published the draft guidance for industry. Comments may be submitted until 25 March 2022.

This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling following revisions to the approved labeling of a reference listed drug (RLD). This guidance provides recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling.

This guidance revises the guidance for industry Revising ANDA Labeling Following Revision of the RLD Labeling (April 2000). After it has been finalized, this guidance will replace the April 2000 guidance. Significant changes from the 2000 version include updates to outdated details about how to obtain information on changes to RLD labeling and how to submit revised ANDA labeling to FDA.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /