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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

15 rows where docket_id = "FDA-2000-N-0108" and posted_year = 2010 sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, posted_date (date), comment_start_date (date), last_modified (date)

document_type 3

  • Supporting & Related Material 13
  • Other 1
  • Rule 1

posted_year 1

  • 2010 · 15 ✖

agency_id 1

  • FDA 15
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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

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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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