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Determination of Regulatory Review Period for Purposes of Patent Extension; SKINVIVE
Federal Register · Notice · May 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 November 10, 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 20471Health and Human Services DepartmentFood and Drug AdministrationMicrobiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
Federal Register · Rule · Aug 25, 2009
days after the comment period on this direct final rule ends. … The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule.
74 FR 42773Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 25, 2016
Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying … out the provisions of the FD&C Act.
81 FR 73410Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BAROSTIM NEO
Federal Register · Notice · Mar 25, 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 September 21, 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 15950Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VELTASSA
Federal Register · Notice · Nov 29, 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 May 29, 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 56609Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OFEV
Federal Register · Notice · Feb 22, 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 21, 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 7747Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AUSTEDO
Federal 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 20896Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZEPATIER
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 4213Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; YONDELIS
Federal Register · Notice · Nov 28, 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 May 29, 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 56246Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; HETLIOZ
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 27261Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; LENVIMA
Federal Register · Notice · Jan 31, 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 4489Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 8, 2001
The comment period for this companion proposed rule runs concurrently with the comment period of the direct final rule. … This comment period runs concurrently with the comment period for the direct final rule; any comments received will be considered as comments regarding the direct final rule.
66 FR 1276Health and Human Services DepartmentFood and Drug AdministrationAdverse Experience Reporting Requirements for Licensed Biological Products
Federal Register · Uncategorized Document · Oct 27, 1994
NCVIA created a new Title XXI of the Public Health Service Act (the PHS Act). … Periodic Reports Three comments on proposed Sec. 600.80(c)(2) noted a discrepancy on when the reporting period begins.
Adverse Experience Reporting Requirements For Licensed BiologicalHealth and Human Services DepartmentFederal Register · Proposed Rule · Aug 9, 2013
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by November 15, 2013 (see the “Paperwork Reduction Act of 1995” section). … FDA-2011-N-0146) with a 120-day comment period.
78 FR 48636Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA
Federal Register · Notice · May 3, 2012
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 by October 30, 2012.
77 FR 26290Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PROLIA
Federal Register · Notice · May 7, 2012
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 by November 5, 2012.
77 FR 26768Health and Human Services DepartmentFood and Drug AdministrationFederal 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 6861Health and Human Services DepartmentFood and Drug AdministrationDefining Small Number of Animals for Minor Use Determination; Periodic Reassessment
Federal Register · Proposed Rule · Sep 15, 2022
30 days after the comment period ends. … The comment period for this proposed rule runs concurrently with the comment period for the companion direct final rule.
87 FR 56604Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ONGLYZA
Federal Register · Notice · Aug 31, 2010
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : December 8, 2001.
75 FR 53315Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SAMSCA
Federal Register · Notice · Dec 14, 2010
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 by June 13, 2011.
75 FR 77879Health and Human Services DepartmentFood and Drug Administration
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