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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-1292" 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 3
  • 2017 2
  • 2018 1
  • 2021 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1292-0007 FDA None FDA-2016-E-1292 Certificate from U.S. Patent and Trademark Office RE Patent Term Extension Other Additional Information 2021-01-22T05:00:00Z 2021 1 2021-01-22T05:00:00Z   2021-01-22T19:30:23Z   0 0 09000064849fd509
FDA-2016-E-1292-0006 FDA None FDA-2016-E-1292 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2018-07-29T04:00:00Z 2018 7 2018-07-29T04:00:00Z   2018-07-29T04:59:21Z   0 0 090000648357add8
FDA-2016-E-1292-0005 FDA None FDA-2016-E-1292 Determination of Regulatory Review Period for Purposes of Patent Extension; REXULTI Notice Determinations 2017-11-29T05:00:00Z 2017 11 2017-11-29T05:00:00Z 2018-01-30T04:59:59Z 2017-11-29T16:37:58Z 2017-25772 0 0 0900006482cbbd2a
FDA-2016-E-1292-0004 FDA None FDA-2016-E-1292 Letter from FDA CDER to the U.S. Patent and Trademark Office Other Letter(s) 2017-08-18T04:00:00Z 2017 8 2017-08-18T04:00:00Z   2017-08-18T18:24:10Z   0 0 0900006482a5134c
FDA-2016-E-1292-0003 FDA None FDA-2016-E-1292 Letter from FDA CDER to the U.S. Patent and Trademark Office Other Letter(s) 2016-08-16T04:00:00Z 2016 8 2016-08-16T04:00:00Z   2016-08-16T17:01:28Z   0 0 090000648217a615
FDA-2016-E-1292-0002 FDA None FDA-2016-E-1292 Letter from U.S. Patent and Trademark Office Other Letter(s) 2016-05-20T04:00:00Z 2016 5 2016-05-20T04:00:00Z   2016-05-20T13:19:35Z   0 0 0900006481fd6d74
FDA-2016-E-1292-0001 FDA None FDA-2016-E-1292 Patent Extension Application from Finnegan, Henderson, Farabow Garrett & Dunner, LLP (on behalf of Otsuka Pharmaceutical Co., Ltd.) Other Application 2016-05-20T04:00:00Z 2016 5 2016-05-20T04:00:00Z   2016-05-20T13:19:05Z   0 0 0900006481fd68d1

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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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