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

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18 rows where docket_id = "FDA-2007-D-0369" and posted_year = 2012 sorted by posted_date descending

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document_type 2

posted_year 1

  • 2012 · 18 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2007-D-0369-0097 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice Notice of Availability 2012-12-17T05:00:00Z 2012 12 2012-12-17T05:00:00Z 2013-02-16T04:59:59Z 2013-02-16T03:01:24Z 2012-30308 0 0 090000648118f5a2
FDA-2007-D-0369-0093 FDA None FDA-2007-D-0369 Guidance for Industry Bioequivalence Recommendations for Specific Products Other Guidance 2012-09-21T04:00:00Z 2012 9 2012-09-21T04:00:00Z   2024-11-12T05:06:22Z   1 0 0900006481121a18
FDA-2007-D-0369-0092 FDA None FDA-2007-D-0369 Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium Capsule; Availability Notice Notice of Data Availability 2012-09-20T04:00:00Z 2012 9 2012-09-20T04:00:00Z 2012-11-20T04:59:59Z 2012-11-19T02:16:02Z 2012-23177 0 0 090000648111feb8
FDA-2007-D-0369-0091 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice Notice of Availability 2012-09-14T04:00:00Z 2012 9 2012-09-14T04:00:00Z 2012-11-14T04:59:59Z 2015-06-13T20:46:53Z 2012-22658 0 0 09000064811171e8
FDA-2007-D-0369-0087 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry; Availability: Describing Product-Specific Bioequivalence Recommendations Notice Notice of Availability 2012-06-14T04:00:00Z 2012 6 2012-06-14T04:00:00Z 2012-08-14T03:59:59Z 2015-03-13T04:55:27Z 2012-14477 0 0 0900006481049abd
FDA-2007-D-0369-0088 FDA None FDA-2007-D-0369 Guidance for Industry Toll Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications Other Guidance 2012-06-14T04:00:00Z 2012 6 2012-06-14T04:00:00Z   2015-03-13T04:56:50Z   0 0 090000648104a3fa
FDA-2007-D-0369-0077 FDA None FDA-2007-D-0369 Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection; Availability Notice Notice of Availability 2012-03-28T04:00:00Z 2012 3 2012-03-28T04:00:00Z 2012-05-30T03:59:59Z 2012-10-03T21:35:21Z 2012-07456 0 0 0900006480fe2f3c
FDA-2007-D-0369-0078 FDA None FDA-2007-D-0369 Draft Guidance on Iron Sucrose; re on Bioequivalence Recommendations for Iron Sucrose Injection Other Guidance 2012-03-28T04:00:00Z 2012 3 2012-03-28T04:00:00Z   2024-11-12T04:48:25Z   1 0 0900006480fe32c1
FDA-2007-D-0369-0076 FDA None FDA-2007-D-0369 Draft Guidance for Industry; Availability: Product-Specific Bioequivalence Recommendations Notice Notice of Data Availability 2012-03-22T04:00:00Z 2012 3 2012-03-22T04:00:00Z 2012-05-22T03:59:59Z 2015-03-13T04:53:48Z 2012-06947 0 0 0900006480fddaca
FDA-2007-D-0369-0075 FDA None FDA-2007-D-0369 Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice Notice of Availability 2012-02-22T05:00:00Z 2012 2 2012-02-22T05:00:00Z   2015-03-13T04:52:46Z 2012-04037 0 0 0900006480fbd6aa
FDA-2007-D-0369-0074 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice Notice of Availability 2012-02-22T05:00:00Z 2012 2 2012-02-22T05:00:00Z   2024-01-30T02:00:18Z 2012-04035 0 0 0900006480fbd63d
FDA-2007-D-0369-0072 FDA None FDA-2007-D-0369 Draft Guidance on Nitroglycerin; Guidance Document Other Guidance 2012-02-13T05:00:00Z 2012 2 2012-02-13T05:00:00Z   2024-11-07T22:27:06Z   1 0 0900006480fb4910
FDA-2007-D-0369-0070 FDA None FDA-2007-D-0369 Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray/ Sublingual Products and Metered Aerosol/Sublingual Products; Availability Notice Notice of Availability 2012-02-13T05:00:00Z 2012 2 2012-02-13T05:00:00Z 2012-04-14T03:59:59Z 2015-03-13T05:13:39Z 2012-03233 0 0 0900006480fb40eb
FDA-2007-D-0369-0069 FDA None FDA-2007-D-0369 Draft Guidance for Industry; Availability: Bioequivalence Recommendations for Rifaximin Tablets Notice Notice of Availability 2012-02-13T05:00:00Z 2012 2 2012-02-13T05:00:00Z 2012-04-14T03:59:59Z 2012-02-13T16:12:13Z 2012-03234 0 0 0900006480fb4000
FDA-2007-D-0369-0073 FDA None FDA-2007-D-0369 Draft Guidance on Nitroglycerin; Guidance Document Other Guidance 2012-02-13T05:00:00Z 2012 2 2012-02-13T05:00:00Z   2024-11-12T05:01:38Z   1 0 0900006480fb4911
FDA-2007-D-0369-0071 FDA None FDA-2007-D-0369 Draft Guidance on Rifaximin Tablets; Guidance Document Other Guidance 2012-02-13T05:00:00Z 2012 2 2012-02-13T05:00:00Z   2024-11-12T04:25:01Z   1 0 0900006480fb4907
FDA-2007-D-0369-0067 FDA None FDA-2007-D-0369 Draft Guidance for Industry; Product-Specific Bioequivalence Recommendations Notice Notice of Availability 2012-01-25T05:00:00Z 2012 1 2012-01-25T05:00:00Z   2024-11-07T22:25:43Z 2012-01433 1 0 0900006480fa3bd9
FDA-2007-D-0369-0065 FDA None FDA-2007-D-0369 Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability - re FDA-2007-D-0433 Notice Notice of Availability 2012-01-17T05:00:00Z 2012 1 2012-01-17T05:00:00Z   2019-08-06T14:36:42Z 2010-14036 0 0 0900006480f985ef

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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;