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Federal Register · Notice · Jun 1, 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 30598Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253
Federal Register · Notice · Apr 23, 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 21298Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 20, 2013
DATES: The FDA is extending the comment period for the proposed rule referenced in the Summary. … Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by November 22, 2013 (see the “Paperwork Reduction Act of 1995” section).
78 FR 69605Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 16, 1998
FDA is providing a 75-day period for comment on this companion proposed rule, to run concurrently with the comment period for the direct final rule. … This comment period begins on June 16, 1998, and ends on August 31, 1998.
63 FR 32772Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Xenical
Federal Register · Notice · May 15, 2001
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 : June 12, 1988.
66 FR 26866Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Plant Sterol/Stanol Esters and Coronary Heart Disease
Federal Register · Rule · Oct 5, 2001
The 75-day comment period closed on November 22, 2000. … Because FDA cannot extend a comment period that has closed, the agency considers these as requests to reopen the comment period.
66 FR 50824Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 23, 2012
ACTION: Proposed rule; reopening of comment period on specific data. … Act of 2007 (Pub.
77 FR 16973Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VIBATIV
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. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: June 27, 2002.
75 FR 77877Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ANGIOMAX
Federal Register · Notice · Dec 16, 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 14, 2011.
75 FR 78714Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; METVIXIA
Federal Register · Notice · Jun 22, 2011
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 FD&C Act) (21 U.S.C. 355(i)) became effective: December 8, 1999.
76 FR 36548Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VPRIV
Federal Register · Notice · Mar 21, 2011
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 FD&C Act) (21 U.S.C. 355(i)) became effective: January 30, 2004.
76 FR 15322Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BROVANA
Federal Register · Notice · Jun 23, 2011
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 FD&C Act) (21 U.S.C. 355(i)) became effective: March 26, 1998.
76 FR 36928Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ARRANON
Federal Register · Notice · Mar 6, 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 9823Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ALTABAX OINTMENT
Federal Register · Notice · Mar 9, 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 10055Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CLEVIPREX
Federal Register · Notice · Oct 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 50801Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FANAPT
Federal Register · Notice · Apr 6, 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 17415Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TOVIAZ
Federal Register · Notice · Apr 6, 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 17414Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GEODON
Federal Register · Notice · Apr 29, 2005
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 3, 1990.
70 FR 22341Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MULTIHANCE
Federal Register · Notice · Jul 11, 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) became effective : July 12, 1994.
71 FR 39120Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BONIVA
Federal Register · Notice · Jun 22, 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) became effective: May 15, 1996.
71 FR 35918Health and Human Services DepartmentFood and Drug Administration
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