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USFDA Guidance: Annual Reportable Labeling Changes for NDA and ANDA for Nonprescription Drug Products

Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released the draft guidance "Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products".

The guidance provides recommendations regarding submitting minor labeling changes in the next annual report to applicants of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nonprescription drug products and provides examples of minor labeling changes that can be submitted.

A nonprescription drug must be labeled with directions for safe use by consumers without the supervision of a healthcare practitioner. These directions should enable consumers to appropriately self-select and use the drug safely and effectively for its intended purposes.

The recommendations in this draft guidance focus on minor labeling changes that are suitable for submission in an annual report. This ensures that consumers have timely access to the most up-to-date labeling for a nonprescription drug product, thereby promoting the product's safe and effective use.

For FDA to approve an application for a nonprescription drug, specific studies may be necessary to show that the drug product can be used safely and effectively without a prescription. This can include consumer studies to demonstrate the product's safety and effectiveness in a nonprescription setting. These studies may include label comprehension studies, self-selection studies, and actual use studies.

By following these recommendations, industry may be able to better understand the situations when minor changes should be documented in the applicant's next annual report rather than submitting a prior approval supplement or a “changes being effected” supplement, thereby reducing FDA and industry burdens.

To see examples of Editorial or Similar Minor Labeling Changes and Additional Considerations for Minor Labeling Changes, click this LINK.


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