The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for COLUMVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
This is a notice published in the Federal Register by Health and Human Services Department, Food and Drug Administration. Notices communicate information, guidance, or policy interpretations but may not create new binding obligations.
This document is classified as a notice. It may or may not create enforceable regulatory obligations depending on its specific content.
Notice.
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by August 19, 2025. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 17, 2025. See "Petitions" in the SUPPLEMENTARY INFORMATION section for more information.
| Document Number | 2025-11321 |
| FR Citation | 90 FR 26314 |
| Type | Notice |
| Published | Jun 20, 2025 |
| Effective Date | - |
| RIN | - |
| Docket ID | Docket Nos. FDA-2024-E-0214 |
| Pages | 26314–26316 (3 pages) |
| Text Fetched | No |
| Part | Name | Agency |
|---|---|---|
| No linked CFR parts | ||
| Type | Proposed | Final | Method | Conf |
|---|---|---|---|---|
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