2025-08443Notice

FDA Sets OMVOH Review Dates for a Possible Patent Extension

Published Date: 5/14/2025

Notice

Summary

The FDA has set the official review period for OMVOH, a human biological product, so its patent holder can apply for extra patent time. If anyone thinks the dates are wrong, they have until July 14, 2025, to speak up. Also, folks can challenge whether the company was diligent during the review by November 10, 2025. This helps protect innovation while keeping the process fair and transparent.

No Economic Impacts Identified for this Document

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Key Dates

Published Date
5/14/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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