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The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EMRELIS 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.
Published
Apr 3, 2026
Comments Close
Jun 2, 2026(46d)
Citation
91 FR 16949
Agencies
2
Full text not available in our database.
View on Federal Register →Get a plain-English explanation of what this regulation does, which agencies are responsible, and how it affects existing rules.
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Docket Nos. FDA-2025-E-3073
FDA-2025-E-3074