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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

33 rows where docket_id = "FDA-2000-N-0108" sorted by posted_date descending

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document_type 4

  • Supporting & Related Material 27
  • Proposed Rule 4
  • Other 1
  • Rule 1

posted_year 2

  • 2003 18
  • 2010 15

agency_id 1

  • FDA 33
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2000-N-0108-0071 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Final Rule re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products: Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans Rule Final Rule 2010-09-29T04:00:00Z 2010 9 2010-09-29T04:00:00Z   2016-02-24T19:19:31Z 2010-24296 0 0 0900006480b63055
FDA-2000-N-0108-0075 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference 5. U.S. Department of Commerce, Bureau of the Census, Economic Census, Manufacturing Industry Series [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule] Supporting & Related Material BKG-Background Material 2010-09-29T04:00:00Z 2010 9     2010-09-29T15:15:36Z   0 0 0900006480b627cb
FDA-2000-N-0108-0074 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference 4. Occupational Employment and Wage Estimates May 2008 [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule] Supporting & Related Material BKG-Background Material 2010-09-29T04:00:00Z 2010 9     2010-09-29T15:13:46Z   0 0 0900006480b627c7
FDA-2000-N-0108-0072 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 List of References re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule Supporting & Related Material List 2010-09-29T04:00:00Z 2010 9     2016-02-25T15:38:49Z   0 0 0900006480b62025
FDA-2000-N-0108-0073 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference 1. "Detailed Guidance on the Collection, Verification and Presentation of Adverse Reaction Reports Arising From Clinical Trials on Medicinal Products for Human Use" [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule] Supporting & Related Material BKG-Background Material 2010-09-29T04:00:00Z 2010 9     2010-09-29T15:03:54Z   0 0 0900006480b62574
FDA-2000-N-0108-0076 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference 6. U.S. Department of Commerce, Bureau of the Census, Economic Census, Manufacturing Industry Series, Biological Product Manufacturing, Table 4 [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule] Supporting & Related Material BKG-Background Material 2010-09-29T04:00:00Z 2010 9     2010-09-29T15:16:51Z   0 0 0900006480b62859
FDA-2000-N-0108-0054 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Shipping Label re Comment from Teva Pharmaceutical Industries Ltd Supporting & Related Material Transmittals 2010-02-27T05:00:00Z 2010 2     2017-08-04T14:14:47Z   0 0 09000064804c2776
FDA-2000-N-0108-0021 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference List - "V.G. References" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006 Supporting & Related Material Background Material 2010-02-26T05:00:00Z 2010 2     2017-08-11T13:34:03Z   0 0 09000064804c26ba
FDA-2000-N-0108-0025 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference 15 - "Agency for Health Care Policy and Research, “National Medical Expenditure Survey: Annual Expenses and Sources of Payment for Health Care Services, Research Findings 14,” p.7, 1995" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006 Supporting & Related Material Background Material 2010-02-26T05:00:00Z 2010 2     2016-02-25T16:25:24Z   0 0 09000064804c26ad
FDA-2000-N-0108-0024 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference 14 -"Statistical Abstract of the United States: The National Data Book, p.137-138, 1999" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006 Supporting & Related Material Background Material 2010-02-26T05:00:00Z 2010 2     2017-08-11T15:01:33Z   0 0 09000064804c26f5
FDA-2000-N-0108-0026 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference 17 - "General Accounting Office, Adverse Drug Events The Magnitude of Health Risk Is Uncertain Because of Limited Incidence Data, GAO/HEHS-00-21, January, 2000" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006 Supporting & Related Material Background Material 2010-02-26T05:00:00Z 2010 2     2016-02-25T16:29:36Z   0 0 09000064804c26d1
FDA-2000-N-0108-0022 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference 10 - "Institute of Medicine, edited by Kohn et al., To Err is Human: Building a Safer Health System, National Academy Press, 1999 " - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006 Supporting & Related Material Background Material 2010-02-26T05:00:00Z 2010 2     2016-02-25T16:35:18Z   0 0 09000064804c26ed
FDA-2000-N-0108-0023 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference 12 - "Department of Health and Human Services, Office of the Inspector General, Review of the Food and Drug Administration’s Handling of Adverse Drug Reaction Reports, Report No. A-15-98-50001, 1999" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006 Supporting & Related Material Background Material 2010-02-26T05:00:00Z 2010 2     2016-02-25T16:35:47Z   0 0 09000064804c26f1
FDA-2000-N-0108-0027 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference 25 - "Eastern Research Group, Inc., “Cost of Implementing MedDRA Terminology for Pharmaceutical and Biologics Companies,”2000" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006 Supporting & Related Material Background Material 2010-02-26T05:00:00Z 2010 2     2016-02-25T16:54:58Z   0 0 09000064804c26bc
FDA-2000-N-0108-0028 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Comment from Bristol-Myers Squibb Pharmaceutical Research Institute Other Letter(s) 2010-02-26T05:00:00Z 2010 2 2010-02-26T05:00:00Z   2016-02-23T19:11:22Z   0 0 09000064804c28fe
FDA-2000-N-0108-0008 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab B - "OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 79-174) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:17:41Z   0 0 09000064804c2946
FDA-2000-N-0108-0012 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab A - "OMB Review March 14, 2003, Executive Order 12866, Substantive Changes Between the Draft Submitted to OIRA and Action Subsequently Announced" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 200-307) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:34:12Z   0 0 09000064804c2951
FDA-2000-N-0108-0018 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab A - "OMB Review March 14, 2003, Executive Order 12866, Substantive Changes Between the Draft Submitted to OIRA and Action Subsequently Announced" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 308-406) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:36:23Z   0 0 09000064804c2967
FDA-2000-N-0108-0013 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab B - "OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 377-464) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:27:30Z   0 0 09000064804c2954
FDA-2000-N-0108-0017 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab B - "OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 278-376) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:21:09Z   0 0 09000064804c2964
FDA-2000-N-0108-0015 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab B - "OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 1-78) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:11:52Z   0 0 09000064804c295e
FDA-2000-N-0108-0011 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab A - "OMB Review March 14, 2003, Executive Order 12866, Substantive Changes Between the Draft Submitted to OIRA and Action Subsequently Announced" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 100-199) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:32:47Z   0 0 09000064804c294e
FDA-2000-N-0108-0009 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference Regulations Policy Management Staff to the Docket, OMB Review March 14, 2003, Executive Order 12866" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2016-02-24T16:51:58Z   0 0 09000064804c294a
FDA-2000-N-0108-0016 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab B - "OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 175-277) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:19:39Z   0 0 09000064804c2961
FDA-2000-N-0108-0014 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab A - "OMB Review March 14, 2003, Executive Order 12866, Substantive Changes Between the Draft Submitted to OIRA and Action Subsequently Announced" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 407-464) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:35:14Z   0 0 09000064804c2957
FDA-2000-N-0108-0010 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab A - "OMB Review March 14, 2003, Executive Order 12866, Substantive Changes Between the Draft Submitted to OIRA and Action Subsequently Announced" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 1-99) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:16:06Z   0 0 09000064804c294b
FDA-2000-N-0108-0007 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Safety Reporting Requirements for Human Drug and Biological Products; Extension of Comment Period Proposed Rule NEC-Notice of Extension 2003-07-01T04:00:00Z 2003 7 2003-06-17T04:00:00Z 2003-10-15T03:59:59Z 2016-12-21T02:02:24Z   0 0 09000064804c2749
FDA-2000-N-0108-0001 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Notice of Proposed Rulemaking re Safety Reporting Requirements for Human Drug and Biological Products See FDA-2000-N-0108-0006 Proposed Rule Notice of Proposed Rulemaking (NPRM) 2003-03-18T05:00:00Z 2003 3 2003-03-18T05:00:00Z 2003-07-15T03:59:59Z 2016-12-24T19:42:06Z   0 0 09000064804c265e
FDA-2000-N-0108-0006 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Notice of Proposed Rulemaking re Safety Reporting Requirements for Human Drug and Biological Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2003-03-18T05:00:00Z 2003 3 2003-03-18T05:00:00Z 2003-07-15T03:59:59Z 2016-02-24T19:29:20Z   0 0 09000064804c2702
FDA-2000-N-0108-0004 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 See FDA-2000-N-0108-0006 Supporting & Related Material   2003-03-18T00:00:00Z 2003 3     2016-03-02T20:20:20Z   0 1 09000064804c26fd
FDA-2000-N-0108-0002 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 See FDA-2000-N-0108-0006 Supporting & Related Material   2003-03-18T00:00:00Z 2003 3     2016-02-24T19:16:56Z   0 1 09000064804c26f7
FDA-2000-N-0108-0003 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 See FDA-2000-N-0108-0006 Proposed Rule   2003-03-18T00:00:00Z 2003 3     2016-03-02T20:23:54Z   0 1 09000064804c26fb
FDA-2000-N-0108-0005 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 See FDA-2000-N-0108-0006 Supporting & Related Material   2003-03-18T00:00:00Z 2003 3     2016-03-02T19:41:42Z   0 1 09000064804c2700

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
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