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33 rows where agency_id = "FDA" and docket_id = "FDA-2000-N-0108" sorted by posted_date descending
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document_type 4
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- 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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);