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

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16 rows where docket_id = "FDA-2014-N-1168" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2014-N-1168-0043 FDA None FDA-2014-N-1168 Appendix A: IMMS Results re: Comment from Teva Pharmaceutical Industries Ltd Supporting & Related Material Background Material 2015-07-14T04:00:00Z 2015 7     2015-07-14T18:21:54Z   0 0 0900006481b842cd
FDA-2014-N-1168-0044 FDA None FDA-2014-N-1168 Appendix B: Attachments and Tables re: Comment from Teva Pharmaceutical Industries Ltd Supporting & Related Material Background Material 2015-07-14T04:00:00Z 2015 7     2015-07-14T18:24:32Z   0 0 0900006481b842ce
FDA-2014-N-1168-0042 FDA None FDA-2014-N-1168 Attachment 1 Executive Summary re: Comment from Teva Pharmaceutical Industries Ltd Supporting & Related Material Background Material 2015-07-14T04:00:00Z 2015 7     2015-07-14T18:20:44Z   0 0 0900006481b842cc
FDA-2014-N-1168-0030 FDA None FDA-2014-N-1168 Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments Proposed Rule Request for Comment 2015-03-05T05:00:00Z 2015 3 2015-03-05T05:00:00Z 2015-06-27T03:59:59Z 2015-07-15T01:31:03Z 2015-05018 0 0 0900006481a2e176
FDA-2014-N-1168-0029 FDA None FDA-2014-N-1168 Generic Drug User Fee Amendments of 2012; September 2014 Public Hearing on Policy Development; Reopening of Docket; Request for Comments Notice Request for Comments 2015-02-06T05:00:00Z 2015 2 2015-02-06T05:00:00Z 2015-03-10T03:59:59Z 2015-03-10T02:02:54Z 2015-02401 0 0 09000064819f7e42
FDA-2014-N-1168-0028 FDA None FDA-2014-N-1168 Transcript Text Version re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014, FDA-2014-N-1168-0026 and FDA-2014-N-1168-0027 Supporting & Related Material Transcript(s) 2015-01-22T05:00:00Z 2015 1     2015-01-22T21:33:34Z   0 0 09000064819d9e78
FDA-2014-N-1168-0026 FDA None FDA-2014-N-1168 Transcript Part 1 re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014 Other Transcript(s) 2015-01-22T05:00:00Z 2015 1 2015-01-22T05:00:00Z   2015-01-22T21:25:10Z   0 0 09000064819d9e76
FDA-2014-N-1168-0027 FDA None FDA-2014-N-1168 Transcript Part 2 re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014 Other Transcript(s) 2015-01-22T05:00:00Z 2015 1 2015-01-22T05:00:00Z   2015-01-22T21:25:17Z   0 0 09000064819d9e77
FDA-2014-N-1168-0025 FDA None FDA-2014-N-1168 Testimony from Marcie Coates re Comment from Mylan Inc. Supporting & Related Material Background Material 2014-12-02T05:00:00Z 2014 12     2014-12-02T16:52:24Z   0 0 090000648193a933
FDA-2014-N-1168-0008 FDA None FDA-2014-N-1168 Slide Presentation from IPEC re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014 Other Presentation 2014-09-19T04:00:00Z 2014 9 2014-09-19T04:00:00Z   2014-09-19T17:44:37Z   0 0 090000648187f826
FDA-2014-N-1168-0009 FDA None FDA-2014-N-1168 Slide Presentation from TEVA Pharmaceuticals, USA re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014 Other Presentation 2014-09-19T04:00:00Z 2014 9 2014-09-19T04:00:00Z   2014-09-19T17:45:03Z   0 0 090000648187f827
FDA-2014-N-1168-0007 FDA None FDA-2014-N-1168 Slide Presentation from PureTek Corporation re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014 Other Presentation 2014-09-19T04:00:00Z 2014 9 2014-09-19T04:00:00Z   2014-09-19T17:43:02Z   0 0 090000648187f7ed
FDA-2014-N-1168-0010 FDA None FDA-2014-N-1168 Slide Presentation from GPhA (Generic Pharmaceutical Association) re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014 Other Presentation 2014-09-19T04:00:00Z 2014 9 2014-09-19T04:00:00Z   2014-09-19T17:43:44Z   0 0 090000648187f825
FDA-2014-N-1168-0006 FDA None FDA-2014-N-1168 Slide Presentation from Perrigo re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014 Other Presentation 2014-09-19T04:00:00Z 2014 9 2014-09-19T04:00:00Z   2014-09-19T17:21:45Z   0 0 090000648187f7ec
FDA-2014-N-1168-0002 FDA None FDA-2014-N-1168 Agenda re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014 Other Agenda 2014-09-16T04:00:00Z 2014 9 2014-09-16T04:00:00Z   2014-09-16T22:42:18Z   0 0 0900006481875a1f
FDA-2014-N-1168-0001 FDA None FDA-2014-N-1168 Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development; Request for Comments Proposed Rule Notice of Hearing 2014-08-19T04:00:00Z 2014 8 2014-08-19T04:00:00Z 2014-10-14T03:59:59Z 2014-11-21T03:02:42Z 2014-19632 0 0 090000648182f82d

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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;