documents

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

19 rows where docket_id = "FDA-2007-D-0369" and posted_year = 2013 sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

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

document_type 3

posted_year 1

  • 2013 · 19 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0369-0279 FDA None FDA-2007-D-0369 Marc Bloomenstein (Schwartz Laser Eye Center) - Letter Other Letter(s) 2013-12-12T05:00:00Z 2013 12 2013-12-12T05:00:00Z   2013-12-12T17:47:56Z   0 0 090000648147aac5
FDA-2007-D-0369-0278 FDA None FDA-2007-D-0369 Supplement from Alison Manson (Prevent Blindness America) Other Supplement (SUP) 2013-12-12T05:00:00Z 2013 12 2013-12-12T05:00:00Z   2014-11-17T17:35:28Z   0 0 090000648147aac6
FDA-2007-D-0369-0277 FDA None FDA-2007-D-0369 Draft Guidance for Industry; Availability: Bioequivalence Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension Notice Notice of Availability 2013-12-05T05:00:00Z 2013 12 2013-12-05T05:00:00Z 2014-02-04T04:59:59Z 2014-02-13T02:02:08Z 2013-29080 0 0 09000064814a9e1e
FDA-2007-D-0369-0275 FDA None FDA-2007-D-0369 Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Reopening of the Comment Period Notice Notice of Availability 2013-11-27T05:00:00Z 2013 11 2013-11-27T05:00:00Z 2013-12-12T04:59:59Z 2013-12-08T18:23:54Z 2013-28394 0 0 090000648149c332
FDA-2007-D-0369-0267 FDA None FDA-2007-D-0369 Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability Notice Notice of Availability 2013-11-06T05:00:00Z 2013 11 2013-11-06T05:00:00Z 2014-01-07T04:59:59Z 2014-01-08T02:03:00Z 2013-26570 0 0 09000064814724f9
FDA-2007-D-0369-0268 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice Notice of Availability 2013-11-06T05:00:00Z 2013 11 2013-11-06T05:00:00Z 2014-01-07T04:59:59Z 2013-12-07T21:29:25Z 2013-26546 0 0 090000648147267c
FDA-2007-D-0369-0264 FDA None FDA-2007-D-0369 Aptalis Pharma US, Inc. - Request for Extension of Comment Period Other Request for Extension 2013-10-30T04:00:00Z 2013 10 2013-10-30T04:00:00Z   2013-10-30T15:56:37Z   0 0 090000648142e65c
FDA-2007-D-0369-0261 FDA None FDA-2007-D-0369 Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Availability Notice Notice of Availability 2013-09-10T04:00:00Z 2013 9 2013-09-10T04:00:00Z 2013-11-27T04:59:59Z 2013-11-20T02:04:23Z 2013-21892 0 0 09000064813ebb62
FDA-2007-D-0369-0244 FDA None FDA-2007-D-0369 Draft Guidance for Industry; Bioequivalence Recommendations for Risperidone Injection; Availability Notice Guidance 2013-08-26T04:00:00Z 2013 8 2013-08-26T04:00:00Z 2013-10-26T03:59:59Z 2013-10-29T01:02:08Z 2013-20696 0 0 09000064813c3adb
FDA-2007-D-0369-0235 FDA None FDA-2007-D-0369 Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories; Availability Notice Notice of Data Availability 2013-08-02T04:00:00Z 2013 8 2013-08-02T04:00:00Z 2013-10-02T03:59:59Z 2013-12-28T03:16:34Z 2013-18629 0 0 090000648138c7e7
FDA-2007-D-0369-0229 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice Notice of Availability 2013-06-20T04:00:00Z 2013 6 2013-06-20T04:00:00Z 2013-08-20T03:59:59Z 2013-08-28T01:02:26Z 2013-14675 0 0 0900006481334132
FDA-2007-D-0369-0117 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances; Availability: Product-Specific Bioequivalence Recommendations re FDA-2007-D-0369-0110 Notice Notice of Availability 2013-04-08T04:00:00Z 2013 4 2013-04-08T04:00:00Z 2013-06-08T03:59:59Z 2013-06-12T01:01:25Z 2013-08013 0 0 0900006481280145
FDA-2007-D-0369-0116 FDA None FDA-2007-D-0369 Draft Guidance for Industry; Bioequivalence Recommendations for Metronidazole Vaginal Gel Other Guidance 2013-04-01T04:00:00Z 2013 4 2013-04-01T04:00:00Z   2024-11-12T05:14:52Z   1 0 0900006481253931
FDA-2007-D-0369-0115 FDA None FDA-2007-D-0369 Draft Guidance for Industry; Availability: Bioequivalence Recommendations for Metronidazole Vaginal Gel Notice Notice of Availability 2013-03-29T04:00:00Z 2013 3 2013-03-29T04:00:00Z 2013-05-29T03:59:59Z 2013-03-29T13:32:00Z 2013-07296 0 0 090000648124f0dd
FDA-2007-D-0369-0112 FDA None FDA-2007-D-0369 Osmotica Pharmaceutical - Supplemental Supporting & Related Material Studies and Reports 2013-03-11T04:00:00Z 2013 3     2013-03-11T19:11:39Z   0 0 0900006481213ece
FDA-2007-D-0369-0110 FDA None FDA-2007-D-0369 Guidance for Industry: Bioequivalence Recommendations for Specific Products Other Guidance 2013-02-27T05:00:00Z 2013 2 2013-02-27T05:00:00Z   2013-05-14T18:39:29Z   0 0 0900006480f985f0
FDA-2007-D-0369-0109 FDA None FDA-2007-D-0369 Sun Pharmaceutical Industries Ltd. - Supplemental Other Supplement (SUP) 2013-02-15T05:00:00Z 2013 2 2013-02-15T05:00:00Z   2013-02-26T00:37:54Z   0 0 09000064811e5678
FDA-2007-D-0369-0107 FDA None FDA-2007-D-0369 Vifor Pharma Ltd (Sidley Austin LLP) - Supplement re FDA-2007-D-0369-0089 Other Supplemental Comment 2013-01-23T05:00:00Z 2013 1 2013-01-23T05:00:00Z   2013-01-23T16:35:34Z   0 0 09000064811c2961
FDA-2007-D-0369-0105 FDA None FDA-2007-D-0369 Electronic Comment from Surgical Migraine Clinic Supporting & Related Material Electronic Comment (EC) 2013-01-15T05:00:00Z 2013 1     2015-03-13T04:25:11Z   0 0 090000648042bb8d

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options: 

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;