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Briefs, oral arguments, agency decisions and the Federal Register.
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Determination of Regulatory Review Period for Purposes of Patent Extension; DEXILANT
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: July 2, 2004.
76 FR 36929Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VOTRIENT
Federal Register · Notice · May 4, 2011
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 31, 2011.
76 FR 25357Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EFFIENT
Federal Register · Notice · Sep 7, 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 March 7, 2011.
75 FR 54344Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; COARTEM
Federal Register · Notice · Dec 10, 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 8, 2011.
75 FR 76990Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; INVEGA SUSTENNA
Federal Register · Notice · Jun 24, 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: June 2, 2003.
76 FR 37128Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BESIVANCE
Federal Register · Notice · Dec 6, 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 6, 2011.
75 FR 75679Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PREVNAR-13
Federal Register · Notice · Mar 31, 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 18035Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Nutrition Labeling, Small Business Exemption
Federal Register · Rule · Aug 7, 1996
This public law extended the time period for compliance with the provisions of section 403(q) of the act until after August 8, 1994, for certain food products. … For products that have been in production for 1 year or more prior to the period for which exemption is claimed, the 12-month period is the period immediately preceding the period for which an exemption
61 FR 40963Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 13, 2013
ACTION: Notification; reopening of the comment period. … Two requesters considered that the comment period for the draft RA should conform to the comment period of the proposed preventive controls rule.
78 FR 15894Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Reports of Corrections and Removals; Companion to Direct Final Rule
Federal Register · Proposed Rule · Aug 7, 1998
The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period. … This comment period runs concurrently with the comment period for the direct final rule. Two copies of any comments are to be submitted, except that individuals may submit one copy.
63 FR 42300Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 24, 2000
The comment period for this companion proposed rule runs concurrently with the direct final rule comment period. … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.
65 FR 3627Health and Human Services DepartmentFood and Drug AdministrationRemoval of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products
Federal Register · Rule · Jan 26, 2018
within 30 days after the comment period on this direct final rule ends. … If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a document confirming the effective date within 30 days after the comment period ends.
83 FR 3586Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NOVOSEVEN
Federal Register · Notice · Jan 24, 2003
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 23, 2003.
68 FR 3534Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZEVALIN
Federal Register · Notice · Apr 21, 2003
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 20, 2003.
68 FR 19547Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CAMPATH
Federal Register · Notice · Jul 13, 2004
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 January 10, 2005.
69 FR 42059Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XOLAIR
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. … 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 31, 2006.
71 FR 4920Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XIGRIS
Federal Register · Notice · Nov 25, 2003
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 May 24, 2004.
68 FR 66112Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; KINERET
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. … 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 March 28, 2005.
69 FR 57938Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 11, 2007
In enacting the Drug Price Competition and Patent Term Restoration Act of 1984 and the Animal Drug and Patent Term Restoration Act of 1988, Congress sought to encourage development of new, safer, and more … In the Federal Register of July 9, 2007 (72 FR 37242), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
72 FR 57950Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PERJETA
Federal Register · Notice · May 19, 2014
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 17, 2014.
79 FR 28734Health and Human Services DepartmentFood and Drug Administration
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