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

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13 rows where agency_id = "FDA" and docket_id = "FDA-2010-D-0589" sorted by posted_date descending

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posted_year 5

agency_id 1

  • FDA · 13 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-D-0589-0034 FDA None FDA-2010-D-0589 Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Guidance for Industry; Availability Notice Notice of Availability 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T12:37:53Z 2020-13745 0 0 0900006484709f79
FDA-2010-D-0589-0035 FDA None FDA-2010-D-0589 Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Guidance for Industry Other Guidance 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2024-11-06T23:37:28Z   1 0 090000648470a6f5
FDA-2010-D-0589-0030 FDA None FDA-2010-D-0589 Attachment 4 ICU I Hospital-Acquired Bacterial Pneumonia (HABP) and VentilatorAssociated Bacterial Pneumonia (VABP) re: Comment from Foundation for the National Institutes of Health Supporting & Related Material Background Material 2017-06-05T04:00:00Z 2017 6     2017-06-05T18:16:22Z   0 0 0900006482690b8d
FDA-2010-D-0589-0031 FDA None FDA-2010-D-0589 Attachment 5 Statistical Tables and Data re: Comment from Foundation for the National Institutes of Health Supporting & Related Material Background Material 2017-06-05T04:00:00Z 2017 6     2017-06-05T18:23:37Z   0 0 0900006482690b8e
FDA-2010-D-0589-0028 FDA None FDA-2010-D-0589 Attachment 1 Statistical Analysis Plan Biomarkers Consortium of the Foundation for the National Institutes of Health HABP/NABP Working Group Part 2 Analysis Version 6.0 re: Comment from Foundation for the National Institutes of Health Supporting & Related Material Background Material 2017-06-05T04:00:00Z 2017 6     2017-06-05T18:09:30Z   0 0 0900006482690d5a
FDA-2010-D-0589-0032 FDA None FDA-2010-D-0589 Attachment 6 Statistical Tables and Data re: Comment from Foundation for the National Institutes of Health Supporting & Related Material Background Material 2017-06-05T04:00:00Z 2017 6     2017-06-05T18:33:11Z   0 0 0900006482690b8f
FDA-2010-D-0589-0029 FDA None FDA-2010-D-0589 Attachment 2 Theravance Biopharma Medicines that make a difference® ATTAIN Studies Overview May 15, 2015 re: Comment from Foundation for the National Institutes of Health Supporting & Related Material Background Material 2017-06-05T04:00:00Z 2017 6     2017-06-05T18:11:25Z   0 0 0900006482690d5b
FDA-2010-D-0589-0020 FDA None FDA-2010-D-0589 Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment Other Guidance 2014-05-14T04:00:00Z 2014 5 2014-05-14T04:00:00Z   2024-11-11T20:51:57Z   1 0 09000064816fad38
FDA-2010-D-0589-0019 FDA None FDA-2010-D-0589 Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment Other Guidance 2014-05-07T04:00:00Z 2014 5 2014-05-07T04:00:00Z   2024-11-11T20:50:01Z   1 0 09000064816e76af
FDA-2010-D-0589-0018 FDA None FDA-2010-D-0589 Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability Notice Notice of Availability 2014-05-07T04:00:00Z 2014 5 2014-05-07T04:00:00Z 2014-08-06T03:59:59Z 2020-04-26T21:14:37Z 2014-10409 0 0 09000064816e6e84
FDA-2010-D-0589-0016 FDA None FDA-2010-D-0589 See Docket FDA-2010-D-0434 Supporting & Related Material   2011-03-23T00:00:00Z 2011 3     2011-10-18T15:12:54Z   0 1 0900006480c05b26
FDA-2010-D-0589-0002 FDA None FDA-2010-D-0589 Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Draft Guidance Other GDL-Guidance (Supporting and Related Materials) 2010-11-30T05:00:00Z 2010 11 2010-11-30T05:00:00Z   2024-11-07T22:24:53Z   1 0 0900006480ba8cff
FDA-2010-D-0589-0001 FDA None FDA-2010-D-0589 Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability Notice NAD-Notice of Availability of Data 2010-11-29T05:00:00Z 2010 11 2010-11-29T05:00:00Z 2011-03-01T04:59:59Z 2011-03-10T20:37:20Z 2010-29799 0 0 0900006480ba7c22

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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;