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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 30597Health 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; PROGENSA PCA3 ASSAY
Federal Register · Notice · May 30, 2014
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.
79 FR 31119Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 19, 1999
30 days after the comment period on the direct final rule ends. … The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule.
64 FR 45375Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ILARIS
Federal Register · Notice · Dec 9, 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 7, 2011.
75 FR 76739Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Avandia
Federal Register · Notice · Feb 13, 2003
Submit electronic comments to http://www.fda/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 7381Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MIFEPREX
Federal Register · Notice · Jan 25, 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 3724Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 10, 2001
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 9, 2001.
66 FR 1992Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 12, 2001
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 11, 2001.
66 FR 2910Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BETAXON
Federal Register · Notice · Jun 26, 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 : July 23, 1997.
67 FR 43128Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; REYATAZ
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 : October 3, 1998.
69 FR 57937Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 30, 2015
ACTION: Notice of proposed rulemaking; reopening of the comment period. … regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
80 FR 74737Health and Human Services DepartmentFood and Drug AdministrationLaboratory Accreditation for Analyses of Foods; Extension of Comment Period
Federal Register · Proposed Rule · Apr 6, 2020
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by July 6, 2020 (see the “Paperwork Reduction Act of 1995” section of the proposed rule). … We also are extending the comment period for the information collection provisions to make the comment period for the information collection provisions the same as the comment period for the provisions
85 FR 19114Health 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 AdministrationIndex of Legally Marketed Unapproved New Animal Drugs for Minor Species
Federal Register · Proposed Rule · Aug 22, 2006
To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. … Comments You may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document.
71 FR 48840Health and Human Services DepartmentFood and Drug AdministrationDesignation of New Animal Drugs for Minor Uses or Minor Species; Reopening of the Comment Period
Federal Register · Proposed Rule · Dec 28, 2005
ACTION: Proposed rule; reopening of the comment period. … FDA is reopening the comment period to update comments and to receive any new information. DATES: Submit written or electronic comments by January 27, 2006.
70 FR 76732Health and Human Services DepartmentFood and Drug Administration
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