documents

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

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27 rows where docket_id = "FDA-2013-N-0500" sorted by posted_date descending

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posted_year 5

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-N-0500-0143 FDA None FDA-2013-N-0500 03- Reference 02- U.S. Department of Health and Human Services, Food and Drug Administration, “Fiscal Year 2019 Justification of Estimates for Appropriations Committees Supporting & Related Material Background Material 2018-12-14T05:00:00Z 2018 12     2018-12-14T15:14:01Z   0 0 09000064839949a4
FDA-2013-N-0500-0141 FDA None FDA-2013-N-0500 01-List of References Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Supporting & Related Material Background Material 2018-12-14T05:00:00Z 2018 12     2018-12-14T15:12:24Z   0 0 09000064839949a2
FDA-2013-N-0500-0140 FDA None FDA-2013-N-0500 Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Proposed Rule Withdrawal 2018-12-14T05:00:00Z 2018 12 2018-12-14T05:00:00Z   2018-12-14T14:36:07Z 2018-27098 0 0 09000064839936bc
FDA-2013-N-0500-0142 FDA None FDA-2013-N-0500 02- Reference 01- Draft guidance for industry, “Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn,” Supporting & Related Material Background Material 2018-12-14T05:00:00Z 2018 12     2018-12-14T15:13:06Z   0 0 09000064839949a3
FDA-2013-N-0500-0139 FDA None FDA-2013-N-0500 Attachment 1 Record of Comments from March 13, 2014 re: Supplemental Comment from Washington Legal Foundation Supporting & Related Material Background Material 2016-04-26T04:00:00Z 2016 4     2016-04-26T18:45:51Z   0 0 0900006481f8f7d2
FDA-2013-N-0500-0136 FDA None FDA-2013-N-0500 Slide Presentations from the March 27 2015 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Public Meeting Redacted Other Presentation 2015-04-29T04:00:00Z 2015 4 2015-04-29T04:00:00Z   2015-04-29T13:25:10Z   0 0 0900006481abfea0
FDA-2013-N-0500-0111 FDA None FDA-2013-N-0500 Agenda for March 27 2015 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Public Meeting Other Agenda 2015-04-24T04:00:00Z 2015 4 2015-04-24T04:00:00Z   2015-04-24T20:16:35Z   0 0 0900006481ab9bdf
FDA-2013-N-0500-0112 FDA None FDA-2013-N-0500 Transcript of March 27 2015 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Public Meeting Other Transcript(s) 2015-04-24T04:00:00Z 2015 4 2015-04-24T04:00:00Z   2015-04-24T21:01:09Z   0 0 0900006481aba131
FDA-2013-N-0500-0105 FDA None FDA-2013-N-0500 Briefs Submitted in Teva Pharmaceuticals USA, Inc. v. Superior Court of Orange County Supporting & Related Material Brief 2015-04-03T04:00:00Z 2015 4     2015-04-03T19:17:49Z   0 0 0900006481a8b7a5
FDA-2013-N-0500-0081 FDA None FDA-2013-N-0500 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period Proposed Rule Public Meeting 2015-02-18T05:00:00Z 2015 2 2015-02-18T05:00:00Z 2015-04-28T03:59:59Z 2015-05-07T01:31:29Z 2015-03211 0 0 0900006481a078f5
FDA-2013-N-0500-0082 FDA None FDA-2013-N-0500 Reference 1 - Joint GPhA PhRMA Letter to Dr Hamburg re Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period Supporting & Related Material Background Material 2015-02-18T05:00:00Z 2015 2     2015-02-18T18:01:50Z   0 0 0900006481a0854b
FDA-2013-N-0500-0080 FDA None FDA-2013-N-0500 Memorandum of Meeting with GPhA (September 8, 2014) Other Memorandum 2014-12-17T05:00:00Z 2014 12 2014-12-17T05:00:00Z   2014-12-19T20:58:41Z   0 0 090000648197f44a
FDA-2013-N-0500-0079 FDA None FDA-2013-N-0500 Supplement from the Generic Pharmaceutical Association Other Supplement (SUP) 2014-07-18T04:00:00Z 2014 7 2014-07-18T04:00:00Z   2014-07-18T13:56:52Z   0 0 0900006481775a8b
FDA-2013-N-0500-0078 FDA None FDA-2013-N-0500 Attachment 3 Revised Virilon Package Insert with Changes Highlighted Supplement from Star Pharmaceuticals, Inc. Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-16T20:38:52Z   0 0 090000648171fbc5
FDA-2013-N-0500-0075 FDA None FDA-2013-N-0500 Supplement from Star Pharmaceuticals, Inc. Other Supplement (SUP) 2014-06-05T04:00:00Z 2014 6 2014-06-05T04:00:00Z   2014-06-05T19:03:19Z   0 0 090000648171fd33
FDA-2013-N-0500-0077 FDA None FDA-2013-N-0500 Attachment 2 Revised Virilon Package Insert re Supplement from Star Pharmaceuticals, Inc. Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-10-24T19:16:16Z   0 0 090000648171fbc4
FDA-2013-N-0500-0076 FDA None FDA-2013-N-0500 Attachment 1 Virilon Drug Listing re Supplement from Star Pharmaceuticals, Inc. Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-10-24T19:15:34Z   0 0 090000648171fad3
FDA-2013-N-0500-0010 FDA None FDA-2013-N-0500 Request for Extension from Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) Other Request for Extension 2014-02-10T05:00:00Z 2014 2 2014-02-10T05:00:00Z   2016-10-31T13:21:42Z   0 0 09000064814c6d0a
FDA-2013-N-0500-0009 FDA None FDA-2013-N-0500 Request for Extension from Mylan Other Request for Extension 2014-02-10T05:00:00Z 2014 2 2014-02-10T05:00:00Z   2016-10-31T13:21:42Z   0 0 09000064814c5e12
FDA-2013-N-0500-0011 FDA None FDA-2013-N-0500 Request for Extension from Perrigo Other Request for Extension 2014-02-10T05:00:00Z 2014 2 2014-02-10T05:00:00Z   2016-10-31T13:21:44Z   0 0 09000064814ca396
FDA-2013-N-0500-0008 FDA None FDA-2013-N-0500 Request for Extension from Academy of Managed Care Pharmacy (AMCP) et al Other Request for Extension 2014-02-10T05:00:00Z 2014 2     2016-10-31T13:21:41Z   0 0 09000064814c4f5c
FDA-2013-N-0500-0007 FDA None FDA-2013-N-0500 Request for Extension from Perrigo Other Request for Extension 2014-02-10T05:00:00Z 2014 2 2014-02-10T05:00:00Z   2016-10-31T13:21:40Z   0 0 09000064814b4789
FDA-2013-N-0500-0006 FDA None FDA-2013-N-0500 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period Proposed Rule Extension of Comment Period 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z 2014-03-14T03:59:59Z 2014-04-10T01:02:03Z 2013-30881 0 0 09000064814debad
FDA-2013-N-0500-0005 FDA None FDA-2013-N-0500 OMB Review Proposed Rule re Executive Order 12866, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 11-13-2013 - Memorandum Other Memorandum 2013-12-13T05:00:00Z 2013 12 2013-12-13T05:00:00Z   2013-12-13T16:08:47Z   0 0 09000064814bc8a9
FDA-2013-N-0500-0004 FDA None FDA-2013-N-0500 Generic Pharmaceutical Association (GPhA) - Request for Extension of Comment Period Other Request for Extension 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z   2013-12-04T20:09:50Z   0 0 090000648149a218
FDA-2013-N-0500-0002 FDA None FDA-2013-N-0500 OMB Review Proposed Rule re Executive Order 12866, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 11-13-2013 - Memorandum Other   2013-11-21T00:00:00Z 2013 11     2013-11-25T14:34:53Z   0 1 090000648148e9e1
FDA-2013-N-0500-0001 FDA None FDA-2013-N-0500 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2013-11-13T05:00:00Z 2013 11 2013-11-13T05:00:00Z 2014-01-14T04:59:59Z 2016-04-26T19:00:32Z 2013-26799 0 0 090000648147a982

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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;