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Determination of Regulatory Review Period for Purposes of Patent Extension; ENSPRYNG
Federal Register · Notice · Jul 13, 2022
Furthermore, any interested person may petition FDA for a determination regarding whether the applicants for extension acted with due diligence during the regulatory review period by January 9, 2023. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
87 FR 41724Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ESPEROCT
Federal Register · Notice · Mar 21, 2023
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 September 21, 2023. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
88 FR 16992Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYME
Federal Register · Notice · Jul 2, 2024
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 30, 2024. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
89 FR 54829Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BEQVEZ
Federal Register · Notice · Feb 6, 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 August 5, 2026. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
91 FR 5499Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AUCATZYL
Federal Register · Notice · Feb 13, 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 August 12, 2026. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
91 FR 6861Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; LUNSUMIO
Federal Register · Notice · Jul 5, 2024
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 January 2, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
89 FR 55628Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DAXXIFY
Federal Register · Notice · Jul 5, 2024
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 January 2, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
89 FR 55597Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OMISIRGE
Federal Register · Notice · Dec 30, 2024
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 June 30, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
89 FR 106492Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIAN
Federal Register · Notice · Dec 30, 2024
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 June 30, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
89 FR 106505Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA
Federal Register · Notice · Dec 29, 2025
Furthermore, any interested person may petition FDA for a determination regarding whether the applicants for extension acted with due diligence during the regulatory review period by June 29, 2026. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension applicants may receive.
90 FR 60727Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
Federal Register · Notice · Apr 3, 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 September 30, 2026. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
91 FR 16949Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SKYCLARYS
Federal Register · Notice · May 12, 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 November 10, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 20169Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO
Federal Register · Notice · May 12, 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 November 10, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 20177Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; KISUNLA
Federal Register · Notice · Jul 14, 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 January 12, 2026. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 31210Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; REBYOTA
Federal Register · Notice · Jul 2, 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 29, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 29024Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; POMBILITI
Federal Register · Notice · Jun 16, 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 15, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 25338Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VOWST
Federal Register · Notice · Jun 16, 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 15, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 25341Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ROLVEDON
Federal Register · Notice · Jun 16, 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 15, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 25328Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BEYFORTUS
Federal Register · Notice · Jun 16, 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 15, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 25331Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SOLX SYSTEM
Federal Register · Notice · Nov 29, 2017
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 May 29, 2018. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
82 FR 56613Health and Human Services DepartmentFood and Drug Administration
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