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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; BEYAZ
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 AdministrationFederal Register · Proposed Rule · Jan 8, 2001
The comment period for this companion proposed rule runs concurrently with the comment period of the direct final rule. … This comment period runs concurrently with the comment period for the direct final rule; any comments received will be considered as comments regarding the direct final rule.
66 FR 1276Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Humanitarian Use of Devices
Federal Register · Rule · Apr 17, 1998
30 days after the comment period on this direct final rule ends. … The comment period for the direct final rule runs concurrently with the comment period of the companion proposed rule.
63 FR 19185Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2013
The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding, among other things, a new chapter granting FDA important authority to regulate the manufacture, marketing … The number of documents received each year since the original collection period has fallen to less than 5 percent of the number received in the original collection period.
78 FR 49527Health and Human Services DepartmentFood and Drug AdministrationAdverse Experience Reporting Requirements for Licensed Biological Products
Federal Register · Uncategorized Document · Oct 27, 1994
NCVIA created a new Title XXI of the Public Health Service Act (the PHS Act). … Periodic Reports Three comments on proposed Sec. 600.80(c)(2) noted a discrepancy on when the reporting period begins.
Adverse Experience Reporting Requirements For Licensed BiologicalHealth and Human Services DepartmentFederal Register · Notice · Oct 5, 2010
This notice solicits comments on FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. … 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
75 FR 61493Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2023
ACTION: Notice of availability; reopening of the comment period. … DATES: FDA is reopening the comment period on the notice of availability published June 8, 2023 (88 FR 37551).
88 FR 55702Health and Human Services DepartmentFood and Drug AdministrationIndex of Legally Marketed Unapproved New Animal Drugs for Minor Species; Extension of Comment Period
Federal Register · Proposed Rule · Oct 2, 2006
ACTION: Proposed rule; extension of comment period. … In the proposed rule, FDA requested comments on implementing regulations for the Federal Food, Drug, and Cosmetic Act (the act) entitled “Index of Legally Marketed Unapproved New Animal Drugs for Minor
71 FR 57892Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 18, 2026
FDA's patent extension activities are conducted under the authority of section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term … Restoration Act of 1988 (Pub.
91 FR 7497Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 24, 2000
The comment period for the direct final rule runs concurrently with the comment period of the companion proposed rule. … The comment period runs concurrently with the comment period for the companion proposed rule. Two copies of any comments are to be submitted, except that individuals may submit one copy.
65 FR 3584Health and Human Services DepartmentFood and Drug AdministrationRevisions to the Requirements Applicable to Blood, Blood Components and Source Plasma
Federal Register · Rule · Aug 16, 2007
The comment period for the direct final rule runs concurrently with the companion proposed 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 45883Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BEPREVE
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 76740Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TORISEL
Federal Register · Notice · Aug 28, 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: May 29, 1998.
77 FR 52035Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NULOJIX
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 18036Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XIAFLEX
Federal Register · Notice · Jun 3, 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 31951Health and Human Services DepartmentFood and Drug AdministrationRemoval of Designated Journals
Federal Register · Rule · Dec 10, 1999
30 days after the comment period on the direct final rule ends. … FDA is providing a period of 75 days for comment on this direct final rule, to run concurrently with the comment period for the companion proposed rule.
64 FR 69188Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RESTYLANE
Federal Register · Notice · Jun 13, 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 34138Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CYPHER
Federal Register · Notice · Feb 3, 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 August 2, 2006.
71 FR 5860Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 3, 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 2, 2011.
75 FR 54152Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2007
This notice solicits comments on FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. … 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
72 FR 37242Health and Human Services DepartmentFood and Drug Administration
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