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Determination 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 AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XADAGO
Federal Register · Notice · Feb 12, 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 August 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 3456Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EXONDYS 51
Federal Register · Notice · Feb 11, 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 August 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 3186Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MITRACLIP CDS
Federal Register · Notice · Oct 23, 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 April 23, 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 49027Health and Human Services DepartmentFood and Drug AdministrationFederal 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 4211Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OSURNIA
Federal Register · Notice · Feb 14, 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: October 21, 2003.
83 FR 6577Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 24, 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 23, 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 50042Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 15, 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 42863Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 11, 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 March 10, 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 56229Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 10, 2015
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.
80 FR 76697Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RESQCPR SYSTEM
Federal Register · Notice · Sep 16, 2016
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.
81 FR 63771Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2016
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.
81 FR 8721Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 29, 1998
30 days after the comment period on this direct final rule ends. … The comment period for the direct final rule runs concurrently with the comment period of the companion proposed rule.
63 FR 51825Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing and Handling of Food
Federal Register · Rule · Jul 21, 2000
Safety Evaluation Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s)), a source of radiation used to treat food is defined as a food additive. … chemical reactions (hereinafter referred to as “radiolysis products”) depend on the chemical constituents of the food and on the conditions of irradiation (e.g., temperature and presence or absence of air
65 FR 45280Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; REMEDE SYSTEM
Federal Register · Notice · Feb 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 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 8287Health and Human Services DepartmentFood and Drug Administration
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