Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
6.21s
Federal Register · Notice · May 15, 2000
Furthermore, any interested person may petition FDA, on or before November 13, 2000, for a determination on whether the applicant for extension acted with due diligence during the regulatory review period … Comments are to be identified with the docket number found in brackets in the heading of this document.
65 FR 31010Health and Human Services DepartmentFood and Drug AdministrationRequirements for Additional Traceability Records for Certain Foods
Federal Register · Rule · Nov 21, 2022
(FD&C Act). … FD&C Act Federal Food, Drug, and Cosmetic Act. FOIA Freedom of Information Act. FSIS Food Safety and Inspection Service. FSMA FDA Food Safety Modernization Act.
87 FR 70910Health 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 AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SPECTRACEF
Federal Register · Notice · Aug 1, 2003
Submit electronic comments to http://www.fda/dockets/ecomments. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
68 FR 45245Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 24, 2003
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.
68 FR 14244Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AVELOX
Federal Register · Notice · Feb 28, 2002
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.
67 FR 9304Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 10, 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 July 9, 2001.
66 FR 1993Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Baycol
Federal Register · Notice · May 11, 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 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: April 19, 1991.
66 FR 24144Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; KEPPRA
Federal Register · Notice · Jan 25, 2002
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.
67 FR 3725Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements for Publication of License Revocation
Federal Register · Rule · May 5, 2009
30 days after the comment period on this direct final rule ends. … If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a document confirming the effective date within 30 days after the comment period ends.
74 FR 20583Health and Human Services DepartmentFood and Drug AdministrationRegulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
Federal Register · Proposed Rule · Sep 20, 2024
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … If any significant adverse comments to the direct final rule are received during the comment period, FDA will publish, within 30 days after the comment period ends, a notice of significant adverse comment
89 FR 77058Health and Human Services DepartmentFood and Drug AdministrationRefuse To Accept Procedures for Premarket Tobacco Product Submissions
Federal Register · Rule · Aug 8, 2016
The comment period for the direct final rule runs concurrently with the companion proposed rule. … Effective Date This direct final rule will be effective 60 days after the comment period ends. VI.
81 FR 52329Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 15, 2017
Background In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
82 FR 43385Health and Human Services DepartmentFood and Drug AdministrationGuidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem
Federal Register · Notice · Jun 24, 1998
Submit comments at any time after the close of the comment period to: Thomas B. Shope (address below). Comments may not be acted upon by the agency until the document is next revised or updated. … After the close of the comment period, comments may be submitted at any time to Thomas B. Shope (address above).
63 FR 34433Health and Human Services DepartmentFood and Drug AdministrationMedical Device User Fee Act; Public Meeting
Federal Register · Notice · Mar 20, 2012
FDA-2010-N-0389] Medical Device User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. … Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the
77 FR 16239Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 25, 2016
ACTION: Notification; extension of comment period. … (the FD&C Act).
81 FR 24041Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 27, 2016
ACTION: Notice; extension of the comment period. … We are, therefore, extending the comment period for the draft guidance for industry entitled “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.”
81 FR 41553Health 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 AdministrationFederal Register · Rule · Jun 10, 2014
Two commenters supported requiring the use of an electronic format for the submission of reports required by section 760 of the FD&C Act. No comments were opposed to such a requirement. … FD&C Act.
79 FR 33072Health 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.