Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Feb 23, 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 22, 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 8088Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TAVALISSE
Federal Register · Notice · Sep 15, 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 March 14, 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 56687Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OLUMIANT
Federal Register · Notice · Feb 6, 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 7, 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 7731Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FYARRO
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 15591Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SOTYKTU
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 15585Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BREXAFEMME
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 14877Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EVRYSDI
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 14875Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PYRUKYND
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 18641Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TRYNGOLZA
Federal Register · Notice · Feb 26, 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 25, 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 9619Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; LUMISIGHT
Federal Register · Notice · Aug 26, 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 February 23, 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 41567Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI
Federal Register · Notice · Dec 29, 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 June 29, 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 60700Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GIVLAARI
Federal Register · Notice · Jun 23, 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 20, 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 32936Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XPOVIO
Federal Register · Notice · Jun 10, 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 7, 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 30945Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MAYZENT
Federal Register · Notice · Jun 10, 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 7, 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 30949Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA
Federal Register · Notice · Aug 21, 2017
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the FD&C Act (21 U.S.C. 355(i)) became effective: October 3, 2006.
82 FR 39587Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NEUROPACE RNS SYSTEM
Federal Register · Notice · Jun 14, 2017
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … 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.
82 FR 27266Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; KAMRA INLAY
Federal Register · Notice · Feb 9, 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 8, 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 5778Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO
Federal Register · Notice · Feb 12, 2018
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the FD&C Act (21 U.S.C. 355(i)) became effective: August 4, 2011.
83 FR 6033Health and Human Services DepartmentFood and Drug AdministrationFederal 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 2452Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 13, 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 November 12, 2019. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
84 FR 20894Health and Human Services DepartmentFood and Drug Administration
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