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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

7 rows where docket_id = "FDA-2016-E-1888" sorted by posted_date descending

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

posted_year 4

  • 2016 4
  • 2017 1
  • 2018 1
  • 2019 1

document_type 2

  • Other 6
  • Notice 1

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-E-1888-0008 FDA None FDA-2016-E-1888 Letter from FDA CDER to the U.S. Patent and Trademark Office Other Letter(s) 2019-03-08T05:00:00Z 2019 3 2019-03-08T05:00:00Z   2019-03-08T12:52:46Z   0 0 0900006483acc287
FDA-2016-E-1888-0006 FDA None FDA-2016-E-1888 Determination of Regulatory Review Period for Purposes of Patent Extension; DARZALEX Notice Determinations 2018-02-20T05:00:00Z 2018 2 2018-02-20T05:00:00Z 2018-08-21T03:59:59Z 2018-02-20T15:02:40Z 2018-03342 0 0 0900006482f45478
FDA-2016-E-1888-0005 FDA None FDA-2016-E-1888 Letter from FDA CDER to the U.S. Patent and Trademark Office Other Letter(s) 2017-06-07T04:00:00Z 2017 6 2017-06-07T04:00:00Z   2017-06-07T16:35:58Z   0 0 09000064826a2084
FDA-2016-E-1888-0004 FDA None FDA-2016-E-1888 Letter from U.S. Patent and Trademark Office to FDA Other Letter(s) 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z   2016-12-27T18:01:50Z   0 0 09000064824380f0
FDA-2016-E-1888-0003 FDA None FDA-2016-E-1888 Letter from FDA CDER to the U.S. Patent and Trademark Office Other Letter(s) 2016-08-26T04:00:00Z 2016 8 2016-08-26T04:00:00Z   2016-08-26T13:26:19Z   0 0 090000648219e752
FDA-2016-E-1888-0002 FDA None FDA-2016-E-1888 Letter from U.S. Patent and Trademark Office Other Letter(s) 2016-07-05T04:00:00Z 2016 7 2016-07-05T04:00:00Z   2016-07-05T18:10:16Z   0 0 09000064820810e0
FDA-2016-E-1888-0001 FDA None FDA-2016-E-1888 Patent Extension Application from Nelson Mullins Riley & Scarborough LLP (on behalf Genmab A/S) Other Application 2016-07-05T04:00:00Z 2016 7 2016-07-05T04:00:00Z   2016-07-05T18:10:07Z   0 0 09000064820810d8

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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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