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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

10 rows where docket_id = "FDA-2011-E-0389" sorted by posted_date descending

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

posted_year 3

  • 2011 4
  • 2012 4
  • 2014 2

document_type 2

  • Other 9
  • Notice 1

agency_id 1

  • FDA 10
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-E-0389-0009 FDA None FDA-2011-E-0389 Letter from U.S. Patent and Trademark Office to McCarter & English LLP Other Letter(s) 2014-08-20T04:00:00Z 2014 8 2014-08-20T04:00:00Z   2014-08-20T13:12:46Z   0 0 09000064818319bf
FDA-2011-E-0389-0010 FDA None FDA-2011-E-0389 Letter from U.S. Patent and Trademark Office to McCarter & English LLP Other Withdrawal 2014-08-20T04:00:00Z 2014 8 2014-08-20T04:00:00Z   2014-08-20T13:19:10Z   0 0 09000064818319c1
FDA-2011-E-0389-0008 FDA None FDA-2011-E-0389 FDA\CDER to U.S. Patent and Trademark Office - Letter Other Letter(s) 2012-12-27T05:00:00Z 2012 12 2012-12-27T05:00:00Z   2012-12-27T15:51:29Z   0 0 090000648119c7d6
FDA-2011-E-0389-0007 FDA None FDA-2011-E-0389 Determination of Regulatory Review Periods for Patent Extension: VIIBRYD Notice General Notice 2012-04-06T04:00:00Z 2012 4 2012-04-06T04:00:00Z 2012-05-06T03:59:59Z 2014-08-20T13:01:36Z 2012-08341 0 0 0900006480feaa04
FDA-2011-E-0389-0006 FDA None FDA-2011-E-0389 FDA\CDER to United States Patent and Trademark Office - Letter Other Letter(s) 2012-04-03T04:00:00Z 2012 4 2012-04-03T04:00:00Z   2012-04-03T19:08:10Z   0 0 0900006480fe7bb3
FDA-2011-E-0389-0005 FDA None FDA-2011-E-0389 U.S. Patent and Trademark Office - Letter Other Letter(s) 2012-03-12T04:00:00Z 2012 3 2012-03-12T04:00:00Z   2012-03-12T15:21:46Z   0 0 0900006480fd3b8b
FDA-2011-E-0389-0004 FDA None FDA-2011-E-0389 FDA\CDER to United States Patent and Trademark Office - Letter Other Letter(s) 2011-06-23T04:00:00Z 2011 6 2011-06-23T04:00:00Z   2011-06-23T15:04:17Z   0 0 0900006480e9c221
FDA-2011-E-0389-0002 FDA None FDA-2011-E-0389 Merk Patent GnbH - Letter Other LET-Letter 2011-05-20T04:00:00Z 2011 5 2011-05-20T04:00:00Z   2011-05-20T14:19:31Z   0 0 0900006480dbbeb6
FDA-2011-E-0389-0003 FDA None FDA-2011-E-0389 U.S. Patent and Trademark Office - Letter Other LET-Letter 2011-05-20T04:00:00Z 2011 5 2011-05-20T04:00:00Z   2013-07-27T23:53:41Z   0 0 0900006480dbbeb7
FDA-2011-E-0389-0001 FDA None FDA-2011-E-0389 Merk Patent GmbH (McCarter & English LLP) - Patent Extension Application Other AAV-Approval of Application 2011-05-20T04:00:00Z 2011 5 2011-05-20T04:00:00Z   2013-07-27T23:53:41Z   0 0 0900006480dbbeb5

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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;
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