The USFDA Revised ANDA Labeling, Following the Revision of the RLD Labeling
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The United States Food and Drug Administration (USFDA) has launched recommendations on identifying Reference Listed Drugs (RLD) labeling updates and submitting ANDA amendments to update generic drug labeling. This draft document is a revised version of ‘Revising ANDA Labeling Following Revision of the RLD Labeling (April 2000),’ and will replace the April 2000 guidance once finalized.
The guidance outlines provisions on how to get information on RLD labeling changes and submit the revised labeling documents in modules. The FDA mentions a section on other considerations to ensure that the applicants comply with the updates made to the labeling of the RLD.
?If you want to know more about the revised RLD labeling regulations for ANDA submissions, please refer to the link. https://www.fda.gov/media/155661/download
?For compliance best practices, reach out to a proven Regulatory expert like Freyr. https://regulatoryaffairs.freyrsolutions.com/abbreviated-new-drug-application-anda-submissions