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[FDA News] Unlocking Compliance: Labeling Changes for OTC NDAs/ANDAs - Plus AR Reporting Examples

Date: 3/12/2024

drug label

Today, the FDA has issued a new guidance titled "Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products," aiming to advise on the types of changes permissible in over-the-counter (OTC) NDA and ANDA product labeling submissions within an annual report.


The guidance underscores the nuanced differences between changes to nonprescription drug labeling and those for prescription products. It emphasizes that alterations to nonprescription labeling can significantly impact consumers' ability to self-select and safely use the product without medical supervision. Consequently, changes that might be considered minor for prescription drugs could be deemed more significant for nonprescription products.


Specifically, the guidance highlights that while certain minor changes, like layout adjustments on prescription drug labels, might not affect safe usage under medical supervision, similar alterations on nonprescription labels could impede consumers' comprehension and proper product selection, thus not qualifying as minor changes.


However, it's important to note that the guidance doesn't cover moderate or major changes to OTC labeling or apply to prescription drug labeling modifications.

In terms of specifics, the FDA outlines eighteen examples of editorial or minor label changes acceptable within an annual report. Yet, it cautions that applicants should evaluate the cumulative impact of multiple minor changes on consumers' understanding of essential labeling information.


Additionally, the guidance stresses that changes to the Drug Facts Label (DFL) generally don't fall under the category of minor changes and may necessitate a different filing-type supplement, except for certain exceptions like alterations in DFL color or tamper-evident statement placement.

Ultimately, while the guidance offers clarity on what constitutes a minor annual-reportable change, it's crucial to carefully consider the FDA's advice when evaluating any modifications.


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