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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

32 rows where docket_id = "FDA-2007-N-0363" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, last_modified, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 4

  • Other 14
  • Supporting & Related Material 14
  • Notice 2
  • Proposed Rule 2

posted_year 3

  • 2007 15
  • 2014 15
  • 2015 2

agency_id 1

  • FDA 32
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2007-N-0363-0059 FDA None FDA-2007-N-0363 Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products; Extension of Comment Period Proposed Rule Extension of Comment Period 2015-03-09T04:00:00Z 2015 3 2015-03-09T04:00:00Z 2015-05-19T03:59:59Z 2015-06-02T01:30:45Z 2015-05336 0 0 0900006481a342ea
FDA-2007-N-0363-0051 FDA None FDA-2007-N-0363 Request for Extension from Pharmaceutical Printed Literature Association (PPLA) and American Forest & Paper Association (AF&PA) Other Request for Extension 2015-02-11T05:00:00Z 2015 2 2015-02-11T05:00:00Z   2016-10-31T15:07:25Z   0 0 09000064819efc0e
FDA-2007-N-0363-0046 FDA None FDA-2007-N-0363 Reference 6 Electronic Distribution of Labeling Proposed Rule Final Report Supporting & Related Material Background Material 2014-12-18T05:00:00Z 2014 12     2014-12-18T20:25:50Z   0 0 0900006481983f98
FDA-2007-N-0363-0044 FDA None FDA-2007-N-0363 Reference 4 Internal Analysis of Safety-Related Labeling Changes Approved by FDA Between 2003 and 2013 Source MedWatch Drug Safety Labeling Changes Supporting & Related Material Background Material 2014-12-18T05:00:00Z 2014 12     2014-12-18T20:22:40Z   0 0 0900006481983be8
FDA-2007-N-0363-0047 FDA None FDA-2007-N-0363 Reference 7 Electronic Distribution of Prescribing Information for Human Prescriptions Drugs Including Biological Products Supporting & Related Material Background Material 2014-12-18T05:00:00Z 2014 12     2014-12-18T20:27:12Z   0 0 0900006481983f99
FDA-2007-N-0363-0042 FDA None FDA-2007-N-0363 Reference 2 Electronic Drug Lageling No Consensus on the Advantages and Disadvantages of Its Exclusive Use Supporting & Related Material Background Material 2014-12-18T05:00:00Z 2014 12     2014-12-18T20:17:51Z   0 0 0900006481983be4
FDA-2007-N-0363-0041 FDA None FDA-2007-N-0363 Reference 1 Final Report Analysis of the Feasibility of Safety Labeling Changes Implementation Timeline Supporting & Related Material Background Material 2014-12-18T05:00:00Z 2014 12     2014-12-18T20:15:54Z   0 0 0900006481983be5
FDA-2007-N-0363-0040 FDA None FDA-2007-N-0363 Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products Proposed Rule Amendment 2014-12-18T05:00:00Z 2014 12 2014-12-18T05:00:00Z 2015-03-19T03:59:59Z 2015-03-19T02:14:33Z 2014-29522 0 0 0900006481982461
FDA-2007-N-0363-0045 FDA None FDA-2007-N-0363 Reference 5 Incidence of New Postmarket Boxed Warnings for New Molecular Entities Supporting & Related Material Background Material 2014-12-18T05:00:00Z 2014 12     2014-12-18T20:24:00Z   0 0 0900006481983f97
FDA-2007-N-0363-0043 FDA None FDA-2007-N-0363 Reference 3 Ho et al An assessment of pharmacists readiness for paperless labeling a national survey Supporting & Related Material Background Material 2014-12-18T05:00:00Z 2014 12     2014-12-18T20:21:00Z   0 0 0900006481983be7
FDA-2007-N-0363-0039 FDA None FDA-2007-N-0363 Withdrawn Supporting & Related Material   2014-12-16T00:00:00Z 2014 12     2014-12-16T18:20:02Z   0 1 090000648197c5c5
FDA-2007-N-0363-0035 FDA None FDA-2007-N-0363 Withdrawn Supporting & Related Material   2014-12-16T00:00:00Z 2014 12     2014-12-16T18:14:17Z   0 1 090000648197c0fb
FDA-2007-N-0363-0037 FDA None FDA-2007-N-0363 Withdrawn Supporting & Related Material   2014-12-16T00:00:00Z 2014 12     2014-12-16T18:16:51Z   0 1 090000648197c5c3
FDA-2007-N-0363-0038 FDA None FDA-2007-N-0363 Withdrawn Supporting & Related Material   2014-12-16T00:00:00Z 2014 12     2014-12-16T18:18:20Z   0 1 090000648197c5c4
FDA-2007-N-0363-0034 FDA None FDA-2007-N-0363 Withdrawn Supporting & Related Material   2014-12-16T00:00:00Z 2014 12     2014-12-16T18:13:28Z   0 1 090000648197c0fa
FDA-2007-N-0363-0036 FDA None FDA-2007-N-0363 Withdrawn Supporting & Related Material   2014-12-16T00:00:00Z 2014 12     2014-12-16T18:16:01Z   0 1 090000648197c5c1
FDA-2007-N-0363-0033 FDA None FDA-2007-N-0363 Withdrawn Supporting & Related Material   2014-12-16T00:00:00Z 2014 12     2014-12-16T18:11:53Z   0 1 090000648197c0f9
FDA-2007-N-0363-0015 FDA None FDA-2007-N-0363 FDA Notice N-Notice 2007-10-24T04:00:00Z 2007 10 2007-10-19T04:00:00Z 2007-12-07T04:59:59Z 2008-04-04T00:36:28Z   0 0 090000648042bacf
FDA-2007-N-0363-0014 FDA None FDA-2007-N-0363 Transcript of April 27, 2007 Hearing Other TR-Transcript 2007-06-11T04:00:00Z 2007 6     2008-04-04T00:36:27Z   0 0 090000648042bab5
FDA-2007-N-0363-0012 FDA None FDA-2007-N-0363 Agenda for April 27, 2007 Public Hearing Other LST-List 2007-04-23T04:00:00Z 2007 4     2008-04-04T00:36:27Z   0 0 090000648042ba9c
FDA-2007-N-0363-0013 FDA None FDA-2007-N-0363 Agenda for April 27, 2007 Public Hearing Other LST-List 2007-04-23T04:00:00Z 2007 4     2008-04-04T00:36:27Z   0 0 090000648042ba9d
FDA-2007-N-0363-0011 FDA None FDA-2007-N-0363 Rickman, William Other EAPE-Electronic Request for Appearance 2007-04-20T04:00:00Z 2007 4     2008-04-04T00:36:27Z   0 0 090000648042ba99
FDA-2007-N-0363-0010 FDA None FDA-2007-N-0363 Fahey, Mike Other EAPE-Electronic Request for Appearance 2007-04-19T04:00:00Z 2007 4     2008-04-04T00:36:27Z   0 0 090000648042ba94
FDA-2007-N-0363-0009 FDA None FDA-2007-N-0363 Pallas, LuAnn Other EAPE-Electronic Request for Appearance 2007-04-16T04:00:00Z 2007 4     2008-04-04T00:36:27Z   0 0 090000648042ba87
FDA-2007-N-0363-0008 FDA None FDA-2007-N-0363 Chan, Carmen Other EAPE-Electronic Request for Appearance 2007-04-16T04:00:00Z 2007 4     2008-04-04T00:36:28Z   0 0 090000648042ba85
FDA-2007-N-0363-0007 FDA None FDA-2007-N-0363 McKeever, Paula Other EAPE-Electronic Request for Appearance 2007-04-13T04:00:00Z 2007 4     2008-04-04T00:36:28Z   0 0 090000648042ba7f
FDA-2007-N-0363-0006 FDA None FDA-2007-N-0363 Spearmon, Jo Ann Other EAPE-Electronic Request for Appearance 2007-04-12T04:00:00Z 2007 4     2008-04-04T00:36:27Z   0 0 090000648042ba78
FDA-2007-N-0363-0004 FDA None FDA-2007-N-0363 Norden, Janet Other EAPE-Electronic Request for Appearance 2007-04-10T04:00:00Z 2007 4     2008-04-04T00:36:27Z   0 0 090000648042ba6d
FDA-2007-N-0363-0005 FDA None FDA-2007-N-0363 Lee, Koung Other EAPE-Electronic Request for Appearance 2007-04-10T04:00:00Z 2007 4     2008-04-04T00:36:27Z   0 0 090000648042ba70
FDA-2007-N-0363-0002 FDA None FDA-2007-N-0363 Garber, Mat Other EAPE-Electronic Request for Appearance 2007-04-03T04:00:00Z 2007 4     2008-08-19T14:18:00Z   0 0 090000648042ba49
FDA-2007-N-0363-0003 FDA None FDA-2007-N-0363 Menchaca, Ramon Other EAPE-Electronic Request for Appearance 2007-04-03T04:00:00Z 2007 4     2008-04-04T00:36:27Z   0 0 090000648042ba4a
FDA-2007-N-0363-0001 FDA None FDA-2007-N-0363 Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing; Request for Comments Notice NHC-Notice of Hearing Before Commissioner 2007-03-28T04:00:00Z 2007 3 2007-03-28T04:00:00Z 2007-06-23T03:59:59Z 2014-11-07T19:16:37Z 07–1604 0 0 090000648042ba47

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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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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