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The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYLOY 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 16952
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-0845
FDA-2025-E-0863
FDA-2025-E-0864
FDA-2025-E-0865
FDA-2025-E-0866
FDA-2025-E-0867
FDA-2025-E-0868
FDA-2025-E-0869
FDA-2025-E-0870
FDA-2025-E-0871
FDA-2025-E-0872