NoticesDocument number 2026-20766New
Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MONOFERRIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 drug product.
From Federal Register — all agencies (federalregister.gov). First seen Oct 10, 2026.
Details
- Published
- Oct 9, 2026Find in source ↗
- Agency
- Health and Human Services Department; Food and Drug AdministrationFind in source ↗
- Comments close
- Dec 8, 2026Find in source ↗
- Action
- Notice.Find in source ↗
- Dates statement
- Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by December 8, 2026. 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 April 7, 2027. See "Petitions" in the SUPPLEMENTARY INFORMATION section for more information.Find in source ↗
- Dockets
- Docket Nos. FDA-2020-E-1882 and FDA-2020-E-1892Find in source ↗
- Citation
- 91 FR 64660Find in source ↗
- Official PDF
- govinfo.gov
History
No changes since RuleWatch first read this rule on Oct 10, 2026.
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