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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; Rimadyl
Federal Register · Notice · Oct 13, 1998
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 512(j) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(j)) became effective: October 30, 1978.
63 FR 54716Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GEMZARRegister
Federal Register · Notice · Aug 3, 1998
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: May 12, 1987.
63 FR 41263Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MirapexRegister
Federal Register · Notice · Aug 7, 1998
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: June 14, 1990.
63 FR 42407Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 20, 1998
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 30, 1987.
63 FR 56035Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 10, 1999
(the act) (21 U.S.C. 201 et seq.) and the Public Health Service Act (42 U.S.C. 262 and 264), FDA is required to ensure the marketing of only those biological products that are shown to be safe and effective … In developing the reproposal, FDA will also consider comments submitted in response to the proposed rule of October 27, 1994, regarding periodic adverse experience reports.
64 FR 11920Health and Human Services DepartmentFood and Drug AdministrationRegulations Regarding “Intended Uses”
Federal Register · Rule · Aug 2, 2021
Introduction We received approximately 15 comment submissions on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues. … An automobile is not subject to regulation by the Federal Aviation Administration, unless it is `intended to be used for flight in the air.' ”) (citations omitted).
86 FR 41383Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 29, 2008
period ends. … The comment period for the direct final rule runs concurrently with that of the companion proposed rule.
73 FR 56487Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 17, 1999
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.
64 FR 32404Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 20, 2017
Comment period closes September 22, 2017 See “Comments”. Request special accommodations due to a disability by August 16, 2017 See FOR FURTHER INFORMATION CONTACT . … Comment period closes January 5, 2018 See “Comments”. Request special accommodations due to a disability by November 28, 2017 See FOR FURTHER INFORMATION CONTACT .
82 FR 33505Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 30, 2021
&C Act (21 U.S.C. 355) (NDAs or ANDAs). … 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.
86 FR 34759Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 8, 2013
Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES … Act of 1995 (PRA) (44 U.S.C. 3501-3520).
78 FR 20926Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 30, 2001
ACTION: Proposed rule; reopening of comment period. … The agency is extending the comment period in response to a request by a group representing pharmaceutical manufacturers.
66 FR 17375Health and Human Services DepartmentFood and Drug AdministrationFood Additives: Food Contact Substance Notification System
Federal Register · Rule · May 21, 2002
FDA agrees with these comments that the 120-day review period for the FCN runs from the date of receipt of a complete notification. … (3) FDA may object to an FCN if any part of FDA’s 120-day review occurs during a period when this program is not funded as required in section 409(h)(5) of the act.
67 FR 35724Health and Human Services DepartmentFood and Drug AdministrationBioavailability and Bioequivalence Requirements; Abbreviated Applications; Final Rule
Federal Register · Rule · Dec 19, 2002
a longer period of time. … (Comment 9) One comment suggested that § 320.26(b)(2) should use an alternative phrase such as “washout period” or “time between dosings” rather than the term “drug elimination period” because that term
67 FR 77668Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 29, 1999
Postmarketing Reporting of Adverse Drug Experiences--21 CFR 310.305 and 314.80 (OMB Control Number 0910-0230--Reinstatement) Section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … In developing the reproposal, FDA will also consider comments submitted in response to the proposed rule of October 27, 1994, regarding periodic adverse experience reports.
64 FR 4665Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 23, 2021
ACTION: Notice; extension of comment period. … DATES: FDA is extending the comment period on the notice published June 15, 2021 (86 FR 31722). Submit either electronic or written comments by August 30, 2021.
86 FR 39047Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 7, 2011
ACTION: Notice; extension of comment period. … The Agency received a comment that the 60-day comment period in the notice was inconsistent with the 90-day comment period in the draft guidance document.
76 FR 68767Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Infergen
Federal Register · Notice · May 14, 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 13, 2001.
66 FR 24389Health and Human Services DepartmentFood and Drug AdministrationAbbreviated New Drug Applications and 505(b)(2) Applications
Federal Register · Rule · Oct 6, 2016
of Comment Period,” 80 FR 22953, April 24, 2015). … We received 13 comment letters on the proposed rule by the close of the comment period, each containing 1 or more comments on 1 or more issues.
81 FR 69580Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AceonSUPTM
Federal Register · Uncategorized Document · Jul 21, 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 505(i) of the Federal Food, Drug, and Cosmetic Act became effective: October 1, 1987.
Health and Human Services DepartmentFood and Drug Administration
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