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Briefs, oral arguments, agency decisions and the Federal Register.
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Determination of Regulatory Review Period for Purposes of Patent Extension; Detectnet
Federal Register · Notice · May 10, 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 November 6, 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 30133Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VERZENIO
Federal Register · Notice · Mar 1, 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 August 28, 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 12938Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VYZULTA
Federal Register · Notice · Mar 1, 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 August 28, 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 12950Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TEGSEDI
Federal Register · Notice · Mar 23, 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 19, 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 17583Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; INQOVI
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 14888Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VOXZOGO
Federal Register · Notice · Mar 4, 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 3, 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 15593Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RECORLEV
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 14870Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VONJO
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 14866Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Amondys 45
Federal Register · Notice · Nov 30, 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 May 28, 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 83545Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Qelbree
Federal Register · Notice · Nov 30, 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 May 28, 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 83548Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Korsuva
Federal Register · Notice · Nov 28, 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 May 28, 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 83136Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SEYSARA
Federal 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 85635Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; WELIREG
Federal Register · Notice · Dec 11, 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 10, 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 85892Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CYTALUX
Federal Register · Notice · Dec 27, 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 24, 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 89458Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SCEMBLIX
Federal Register · Notice · Dec 27, 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 24, 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 89456Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FILSPARI
Federal Register · Notice · Jun 25, 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 22, 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 27021Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZEVTERA
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 25316Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; QALSODY
Federal Register · Notice · Jun 20, 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 17, 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 26302Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VELSIPITY
Federal Register · Notice · Jun 20, 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 17, 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 26316Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; JOENJA
Federal Register · Notice · Jun 20, 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 17, 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 26306Health and Human Services DepartmentFood and Drug Administration
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