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    Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: FDA determines regulatory review period for ELAHERE, (May 20, 2025)

    By WK Editorial Staff

    The FDA has determined the regulatory review period for ELAHERE and is publishing the notice of that determination as required by law.

    The FDA has made the determination because of the submission of an application to the Director of the U.S. Patent an ...

    By WK Editorial Staff

    The FDA has determined the regulatory review period for ELAHERE and is publishing the notice of that determination as required by law.

    The 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 biological product (Notice, 90 Fed. Reg. 21311 (May. 19, 2025)).

    Dates. Anyone with knowledge that any of the dates as published are incorrect must submit either electronic or written comments and ask for a redetermination by July 18, 2025. Any interested person may petition the FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 17, 2025.

    FederalRegisterIssuances: Notices FDCActNews DrugBiologicNews

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