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Determination of Regulatory Review Period for Purposes of Patent Extension; ONSIOR
Federal Register · Notice · Apr 2, 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 numbers found in brackets in the heading of this document.
79 FR 18563Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; IXEMPRA
Federal Register · Notice · Nov 10, 2008
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 : July 30, 1999.
73 FR 66646Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TYKERB
Federal Register · Notice · Nov 10, 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 May 11, 2009.
73 FR 66647Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FLUBLOK
Federal Register · Notice · Apr 24, 2015
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.
80 FR 23034Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TUDORZA PRESSAIR
Federal Register · Notice · May 4, 2015
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.
80 FR 25303Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SIGNIFOR
Federal Register · Notice · May 7, 2015
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.
80 FR 26276Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MYRBETRIQ
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 30622Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; INLYTA
Federal Register · Notice · May 23, 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 29783Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; INVEGA
Federal Register · Notice · May 14, 2008
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 : February 14, 2003.
73 FR 27837Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA
Federal Register · Notice · May 15, 2008
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 : July 1, 2000.
73 FR 28119Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SOMATULINE DEPOT
Federal Register · Notice · Nov 17, 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 May 18, 2009.
73 FR 67874Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; LASTACAFT
Federal Register · Notice · May 3, 2012
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: August 1, 2004.
77 FR 26291Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Victoza
Federal Register · Notice · May 2, 2012
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 24, 2012.
77 FR 26018Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XALKORI
Federal Register · Notice · Jan 31, 2013
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 30, 2013.
78 FR 6826Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Medical Device Reporting; Baseline Reports
Federal Register · Rule · Jun 13, 2008
days after the comment period on this direct final rule ends. … The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule.
73 FR 33692Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 16, 2020
ACTION: Notice; reopening of the comment period. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020-22969 Filed 10-15-20; 8:45 am] BILLING CODE 4164-01-P
85 FR 65819Health and Human Services DepartmentFood and Drug AdministrationFederal 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 30623Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 16, 2022
The Consolidated Appropriations Act of 2022 (the Appropriations Act), enacted on March 15, 2022, amended the definition of the term “tobacco product” in section 201(rr) (U.S.C. 321(rr)) of the FD&C Act … Additionally, the Appropriations Act includes a transition period for premarket review requirements, directing companies to submit PMTAs for NTN products by May 14, 2022, to receive an additional 60-day
87 FR 29749Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 12, 2008
(the PHS Act) (42 U.S.C. 264). … Since the Expedited Reports and Periodic Reports draft guidances were issued, the agency has received ICSRs for HCT/Ps regulated under section 361 of the PHS Act.
73 FR 33436Health and Human Services DepartmentFood and Drug AdministrationSugars That Are Metabolized Differently Than Traditional Sugars; Extension of Comment Period
Federal Register · Notice · Dec 18, 2020
ACTION: Notification; extension of comment period. … We have concluded that it is reasonable to extend the comment period for 60 days.
85 FR 82489Health and Human Services DepartmentFood and Drug Administration
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