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Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV
Federal Register · Notice · Jun 29, 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 December 28, 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 39103Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TRYVIO
Federal Register · Notice · Jan 27, 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 July 27, 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 3508Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GEMTESA
Federal Register · Notice · Feb 29, 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 August 27, 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 14883Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NULIBRY
Federal Register · Notice · Feb 29, 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 August 27, 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 14851Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XERAVA
Federal Register · Notice · Feb 29, 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 August 27, 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 14886Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZAVZPRET
Federal Register · Notice · Sep 25, 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 March 24, 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 78309Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VTAMA
Federal Register · Notice · Mar 14, 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 September 10, 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 18646Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 18, 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 April 16, 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 83890Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TAZVERIK
Federal Register · Notice · Jun 28, 2021
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 27, 2021. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
86 FR 34022Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BALVERSA
Federal Register · Notice · Jun 30, 2021
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 27, 2021. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
86 FR 34764Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BARHEMSYS
Federal Register · Notice · Jul 7, 2021
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 3, 2022. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
86 FR 35803Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FETROJA
Federal Register · Notice · Jun 30, 2021
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 27, 2021. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
86 FR 34762Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 21, 2018
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 19, 2019. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
83 FR 65680Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 4, 2018
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 3, 2019. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
83 FR 62593Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ASPIRE ASSIST
Federal Register · Notice · Dec 4, 2018
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 3, 2019. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
83 FR 62580Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; JUVEDERM VOLUMA XC
Federal Register · Notice · Feb 14, 2018
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 13, 2018. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
83 FR 6574Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 22, 2018
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 July 23, 2018 See “ … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
83 FR 2997Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 11, 2017
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
82 FR 31974Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 8, 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 June 5, 2024. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
88 FR 85643Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 1, 2021
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 28, 2021. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
86 FR 17167Health and Human Services DepartmentFood and Drug Administration
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