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Determination of Regulatory Review Period for Purposes of Patent Extension; SPINRAZA
Federal Register · Notice · Nov 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 May 2, 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 60248Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 27, 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 April 25, 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 59392Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TABRECTA
Federal Register · Notice · Jul 11, 2022
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 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 41133Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RINVOQ
Federal Register · Notice · Jul 7, 2022
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, 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 40536Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VIEKIRA PAK
Federal Register · Notice · Jan 30, 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 30, 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 4218Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AVYCAZ
Federal Register · Notice · Jan 17, 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 16, 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 2449Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ORKAMBI
Federal Register · Notice · Feb 15, 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 14, 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 6868Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; KENGREAL
Federal Register · Notice · Aug 30, 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 February 26, 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 41274Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CORLANOR
Federal Register · Notice · Feb 1, 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 31, 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 4661Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GENVOYA
Federal Register · Notice · Feb 7, 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 6, 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 5431Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AKYNZEO
Federal Register · Notice · Feb 12, 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 6038Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GILOTRIF
Federal Register · Notice · Feb 12, 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 6026Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FARYDAK
Federal Register · Notice · Feb 13, 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 6198Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BEVYXXA
Federal Register · Notice · Aug 30, 2019
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 February 26, 2020. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
84 FR 45778Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GIAPREZA
Federal Register · Notice · Sep 5, 2019
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 3, 2020. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
84 FR 46740Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; INGREZZA
Federal Register · Notice · Mar 5, 2020
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 1, 2020. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
85 FR 12928Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; INTRAROSA
Federal Register · Notice · Feb 18, 2020
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 17, 2020. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
85 FR 8879Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XEPI
Federal Register · Notice · Jul 13, 2020
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 11, 2021. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
85 FR 41996Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RUBRACA
Federal Register · Notice · Dec 28, 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 26, 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 67290Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV
Federal Register · Notice · Dec 28, 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 26, 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 67293Health and Human Services DepartmentFood and Drug Administration
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