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Determination of Regulatory Review Period for Purposes of Patent Extension; KEYTRUDA
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 4492Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL 9
Federal Register · Notice · Dec 7, 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 88245Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 4, 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 January 31, 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 51839Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 28, 2007
Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
72 FR 14582Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 28, 1996
Public Comments on Increased Frequency Report Requirements In the October 27, 1994, proposed rule, FDA proposed to amend its regulations for expedited and periodic premarketing and postmarketing safety … Act of 1995 (Pub.
61 FR 55602Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PREVNAR-20
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 14849Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SOLIRIS
Federal Register · Notice · Mar 4, 2009
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
74 FR 9406Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TEKTURNA
Federal Register · Notice · May 2, 2008
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
73 FR 24295Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 8, 2009
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
74 FR 21696Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MOZOBIL
Federal Register · Notice · Apr 9, 2010
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
75 FR 18213Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BANZEL
Federal Register · Notice · Sep 4, 2009
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
74 FR 45864Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; LEXISCAN
Federal Register · Notice · Aug 24, 2009
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
74 FR 42678Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FIRMAGON
Federal Register · Notice · Mar 1, 2010
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
75 FR 9227Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ABLAVAR
Federal Register · Notice · Jun 8, 2010
ADDRESSES: Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
75 FR 32479Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AFINITOR
Federal Register · Notice · Apr 14, 2010
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
75 FR 19406Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SAVELLA
Federal Register · Notice · Apr 14, 2010
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
75 FR 19407Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Synercid
Federal Register · Notice · Sep 21, 2001
Submit electronic comments to http://www.fda.gov/dockets/ecomments. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
66 FR 48690Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VESICARE
Federal Register · Notice · Mar 23, 2006
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 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective : May 5, 1999.
71 FR 14708Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EMEND
Federal Register · Notice · Aug 3, 2006
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 : May 10, 1996.
71 FR 44033Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ELAPRASE
Federal Register · Notice · May 23, 2007
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 : January 25, 2001.
72 FR 28980Health and Human Services DepartmentFood and Drug Administration
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