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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; MENHIBRIX
Federal Register · Notice · May 28, 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 30621Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ROTATEQ
Federal Register · Notice · Jun 11, 2008
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 December 8, 2008.
73 FR 33095Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Uvasorb HA88
Federal Register · Notice · May 16, 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 November 12, 2001.
66 FR 27149Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 23, 2021
For example, at the Public Hearing, almost all commenters agreed that HHS should have lengthened the comment period, and offered several reasons in support of a longer comment period, all of which were … In addition, the Department previously took the view that a 30-day comment period was adequate.
86 FR 15404Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 29, 1998
The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period. … The comment period runs concurrently with the comment period for the direct final rule. Two copies of any comment are to be submitted except that individuals may submit one copy.
63 FR 51874Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FABRAZYME
Federal Register · Notice · Mar 15, 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 September 13, 2004.
69 FR 12159Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ENBREL
Federal Register · Notice · May 28, 2002
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
67 FR 36897Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ACRYSOF
Federal Register · Notice · Apr 2, 2008
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.
73 FR 17985Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DERAMAXX
Federal Register · Notice · Dec 1, 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 67194Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; LANTUS
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 30595Health and Human Services DepartmentFood and Drug AdministrationFederal 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 AdministrationFederal Register · Proposed Rule · Nov 12, 2019
ACTION: Proposed rule; additional materials; reopening of the comment period. … FDA is placing additional materials in the docket and reopening the comment period for the proposed rule for 15 days to allow comment on the additional materials.
84 FR 60966Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug Product Labeling; Medication Guide Requirements; Extension of Comment Period
Federal Register · Proposed Rule · Nov 24, 1995
Accordingly, the comment period is extended to December 22, 1995. … Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. Dated: November 13, 1995. William K. Hubbard, Acting Deputy Commissioner for Policy.
60 FR 58025Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PROFENDER
Federal Register · Notice · Mar 12, 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 10744Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VETMEDIN
Federal Register · Notice · Feb 10, 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 6639Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 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 52241Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 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 45865Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XIENCE V EECSS
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 38659Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CLINACOX
Federal Register · Notice · Aug 3, 2006
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.
71 FR 44032Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CYDECTIN
Federal Register · Notice · Sep 20, 2006
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.
71 FR 54993Health and Human Services DepartmentFood and Drug Administration
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