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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; IMFINZI
Federal Register · Notice · Oct 19, 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 April 17, 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 53067Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DARZALEX
Federal Register · Notice · Feb 20, 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 20, 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 7192Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TAKHZYRO
Federal Register · Notice · Sep 14, 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 15, 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 56622Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 16, 2022
The Consolidated Appropriations Act of 2022 (the Appropriations Act), enacted on March 15, 2022, amended the definition of the term “tobacco product” in section 201(rr) (U.S.C. 321(rr)) of the FD&C Act … Additionally, the Appropriations Act includes a transition period for premarket review requirements, directing companies to submit PMTAs for NTN products by May 14, 2022, to receive an additional 60-day
87 FR 29749Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 10, 2022
FDA's patent extension activities are conducted under the authority of section 505(j) of the Federal, Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(j)) and the Generic Animal Drug and Patent … Term Restoration Act of 1988 ((Pub.
87 FR 48667Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CYRAMZA
Federal Register · Notice · Apr 15, 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 22276Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; JETREA
Federal Register · Notice · Dec 23, 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 79903Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RAXIBACUMAB
Federal Register · Notice · Dec 15, 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 77643Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; REPATHA
Federal Register · Notice · Oct 19, 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 72059Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OPDIVO
Federal Register · Notice · Dec 2, 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 87044Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BEXSERO
Federal Register · Notice · Dec 5, 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 87568Health and Human Services DepartmentFood and Drug AdministrationRegulation of Tobacco Products; Extension of Comment Period
Federal Register · Notice · Oct 1, 2009
Background In the Federal Register of July 1, 2009 (74 FR 31457), FDA published a notice with a 90-day comment period to request comments on the implementation of the Tobacco Act. … Comments from the public will inform FDA's actions implementing the Tobacco Act. The agency has received a request for an extension of the comment period for the notice.
74 FR 50810Health and Human Services DepartmentFood and Drug AdministrationAbbreviated New Drug Applications and 505(b)(2) Applications; Extension of Comment Period
Federal Register · Proposed Rule · Apr 24, 2015
ACTION: Proposed rule; extension of comment period. … of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs).
80 FR 22953Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Cablivi
Federal Register · Notice · May 15, 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 13, 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 30983Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZYNLONTA
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 85633Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TALVEY
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 26317Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ALTUVIIIO
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 26312Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; WINREVAIR
Federal Register · Notice · Jul 2, 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 29, 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 29018Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; IMDELLTRA
Federal Register · Notice · Jul 14, 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 January 12, 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 31215Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TECELRA
Federal Register · Notice · Jul 14, 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 January 12, 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 31228Health and Human Services DepartmentFood and Drug Administration
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