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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; CHANTIX
Federal Register · Notice · Jun 7, 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 : October 15, 1999.
72 FR 31588Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 12, 2008
-day period of continued violation after the first 30-day period 2007 1,000,000 (not adjusted) 333(f)(4)(A)(ii) 10,000,000 For all violations adjudicated in a single proceeding 2007 10,000,000 … (not adjusted) 333(g)(1) 250,000 For the first violation in any 3-year period 2007 250,000 (not adjusted) 333(g)(1) 500,000 For each subsequent violation in any 3-year period
73 FR 66750Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2011
L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 13631Health 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 AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; S8 OVER-THE-WIRE SYSTEM
Federal Register · Notice · Feb 23, 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 8182Health and Human Services DepartmentFood and Drug AdministrationVeterinary Feed Directive; Extension of Comment Period
Federal Register · Proposed Rule · Jun 28, 2010
ACTION: Advance notice of proposed rulemaking; extension of comment period. … The agency has received requests for a 60-day extension of the comment period for the ANPRM.
75 FR 36588Health 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 AdministrationFederal Register · Proposed Rule · Aug 16, 2007
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553).
72 FR 45993Health and Human Services DepartmentFood and Drug AdministrationRegulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
Federal Register · Rule · Sep 20, 2024
The comment period for the direct final rule runs concurrently with the comment period for the companion proposed rule. … 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.
89 FR 77019Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT-NDA 22-254
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 21299Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 14, 1999
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 confirmation document within 30 days after the comment period ends, confirming the effective
64 FR 26282Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; HUMIRA
Federal Register · Notice · Feb 1, 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 5342Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PEG-Intron
Federal Register · Notice · Jul 16, 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 46680Health and Human Services DepartmentFood and Drug Administration
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