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Federal Register · Notice · Nov 1, 2024
no major amendments to an OMOR be accepted by the Agency after the public comment period for a proposed order has closed. … The statute also gives flexibility for the public comment period on proposed orders to be extended.
89 FR 87376Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 11, 1998
The comment period for the direct final rule runs concurrently with that of the companion proposed rule. … Extend compliance period. FDA considered an extended compliance period.
63 FR 25764Health and Human Services DepartmentFood and Drug AdministrationDraft Guidance for Industry on Developing Medical Imaging Drugs and Biologics; Availability
Federal Register · Proposed Rule · Oct 14, 1998
In a separate document published elsewhere in this issue of the Federal Register, FDA is further extending the comment period to November 16, 1998. … Persons will have additional time to submit comments on the draft guidance after the comment period on the proposed rule closes.
63 FR 55067Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 12, 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 comments are to be submitted, except that individuals may submit one copy.
63 FR 26129Health 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 AdministrationFederal Register · Notice · Oct 19, 2009
FDA-2009-N-0143] Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. … ACTION: Notice; reopening of comment period.
74 FR 53509Health and Human Services DepartmentFood and Drug AdministrationAntimicrobial Animal Drug Sales and Distribution Reporting
Federal Register · Rule · May 11, 2016
, including periodic drug experience reports under § 514.80(b)(4). … We received approximately 440 individual comments on the proposed rule by the close of the comment period, each addressing one or more topics.
81 FR 29129Health and Human Services DepartmentFood and Drug AdministrationImport Tolerances; Extension of Comment Period
Federal Register · Proposed Rule · Dec 7, 2001
ACTION: Advance notice of proposed rulemaking; extension of comment period. … period 90 days.
66 FR 63519Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 11, 2014
ACTION: Notification of public scoping meeting; extension of comment period for the Environmental Impact Statement. … FSMA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation of a modernized, prevention-based food safety system.
79 FR 13593Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 1, 2006
ACTION: Proposed rule; reopening of the comment period. … Act (the act) (21 U.S.C. 350a).
71 FR 43392Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 11, 1995
Several comments stated that 10 days is too short a time period for user facilities to report adverse events properly. … FDA cannot agree because the 10-day time period is the maximum time allowed by the statute. (See section 519(b)(1)(A) of the act.)
60 FR 63578Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AlbunexRegister
Federal Register · Notice · Mar 2, 1995
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
60 FR 11671Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AviaxRegister
Federal Register · Uncategorized Document · Sep 6, 1994
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act became effective: July 9, 1987.
Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Lumbar I/F Cage®
Federal Register · Uncategorized Document · Jan 31, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
65 FR 4616Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NeumegaRegister
Federal Register · Notice · May 19, 1999
Under these acts, a product's regulatory review period forms the basis [[Page 27272]] 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: October 30, 1992.
64 FR 27271Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 19, 1999
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
64 FR 27273Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TazoracRegister
Federal Register · Notice · May 20, 1999
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: February 8, 1990.
64 FR 27578Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FemaraRegister
Federal Register · Notice · May 10, 1999
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: August 28, 1991.
64 FR 25046Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DenavirSUPTM/SUP
Federal Register · Notice · May 10, 1999
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: March 7, 1993.
64 FR 25047Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AmergeSUPTM/SUP
Federal Register · Notice · Apr 29, 1999
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 5, 1995.
64 FR 23086Health and Human Services DepartmentFood and Drug Administration
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