Annual Updates on Labeling Changes for New Drug Applications and Abbreviated New Drug Applications Regarding Nonprescription Medications

Overview

On March 2024, the FDA is releasing a draft guidance for industry that, once finalized, will offer suggestions to holders of approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for nonprescription drug products on how to document minor labeling changes in their subsequent annual reports.

Introduction

The Food and Drug Administration (FDA, Agency,) is notifying the public about a draft guidance for industry titled “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products.” This draft guidance offers suggestions to applicants of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nonprescription drug products regarding the documentation of minor labeling changes in the subsequent annual report. Additionally, it includes examples of minor labeling changes that could be included in such reports.

The recommendations:

The suggestions outlined in this draft guidance pertain to the kinds of minor labeling modifications suitable for inclusion in an annual report.

This aims to guarantee that consumers can promptly access the latest labeling information for a nonprescription drug product, thus ensuring its safe and effective utilization. By following these recommendations, the industry can better comprehend the situations wherein documenting minor changes in the applicant’s subsequent annual report is preferable over submitting a prior approval supplement or a “changes being effected” supplement.

This approach serves to alleviate burdens both on the industry and on the FDA.

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Annual Reportable Labeling Changes

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References

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