Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.28s
Federal Register · Notice · Jun 10, 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 33199Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZACTRAN
Federal Register · Notice · May 29, 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 30854Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 23, 2024
under section 760(c)(2) of the FD&C Act. … Section 760(e) of the FD&C Act also requires that responsible persons maintain records of nonprescription drug adverse event reports, whether the event is serious or not, for a period of 6 years.
89 FR 77515Health 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; 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 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; 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; 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 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 AdministrationFederal Register · Notice · Dec 12, 2019
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … review period.
84 FR 67947Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Humanitarian Use of Devices; Companion to Direct Final Rule
Federal Register · Proposed Rule · Apr 17, 1998
The comment period for this companion proposed rule runs concurrently with the direct final rules'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 19196Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SENSIPAR
Federal Register · Notice · May 14, 2009
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 : June 21, 1998.
74 FR 22750Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Rescula
Federal Register · Notice · Sep 21, 2001
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 : November 27, 1996.
66 FR 48689Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; KETEK
Federal Register · Notice · Sep 26, 2006
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 : March 20, 1998.
71 FR 56156Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TYGACIL
Federal Register · Notice · Jun 13, 2006
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 : August 26, 1998.
71 FR 34139Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OVIDREL
Federal Register · Notice · Mar 15, 2006
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 : November 1, 1995.
71 FR 13406Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 25, 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 : April 4, 2003.
72 FR 29334Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; LUCENTIS
Federal Register · Notice · May 29, 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 November 25, 2008.
73 FR 30949Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; YERVOY
Federal Register · Notice · May 1, 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 24735Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.