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Determination of Regulatory Review Period for Purposes of Patent Extension; EOVIST
Federal Register · Notice · Aug 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 38660Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TAPENTADOL HYDROCHLORIDE
Federal Register · Notice · Sep 1, 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 45225Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; INTELENCE
Federal Register · Notice · May 22, 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 24014Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PROMACTA
Federal Register · Notice · Jun 10, 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 32951Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; UROXATRAL
Federal Register · Notice · Jun 13, 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 : September 1, 1996.
71 FR 34137Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ALIMTA
Federal Register · Notice · Feb 8, 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 : September 10, 1992.
71 FR 6504Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OMACOR
Federal Register · Notice · Feb 2, 2006
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 August 1, 2006.
71 FR 5669Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SPIRIVA HANDIHALER
Federal Register · Notice · Jan 27, 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 : January 1, 1995.
71 FR 4592Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ENABLEX
Federal Register · Notice · Jan 30, 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 : July 6, 1994.
71 FR 4919Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; LOTRONEX
Federal Register · Notice · Nov 14, 2002
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 10, 1990.
67 FR 69014Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SOLAGE
Federal Register · Notice · Nov 14, 2002
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.
67 FR 69016Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VISUDYNE
Federal Register · Notice · Sep 28, 2004
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 : July 17, 1991.
69 FR 57939Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 2, 2004
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 : November 2, 1989.
69 FR 63547Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OP-1 IMPLANT
Federal Register · Notice · Apr 2, 2003
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.
68 FR 16062Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AROMASIN
Federal Register · Notice · Apr 28, 2003
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 : March 6, 1991.
68 FR 22390Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VFEND
Federal Register · Notice · Apr 18, 2003
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: September 8, 1995.
68 FR 19212Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Heart Laser System
Federal Register · Notice · Jan 18, 2002
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 July 17, 2002.
67 FR 2663Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EVISTA
Federal Register · Notice · Feb 28, 2002
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 : February 16, 1983.
67 FR 9300Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RELENZA
Federal Register · Notice · Feb 27, 2002
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 : August 23, 1994.
67 FR 8988Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Celexa
Federal Register · Notice · Feb 25, 2002
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 : July 30, 1983.
67 FR 8546Health and Human Services DepartmentFood and Drug Administration
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