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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

9 rows where docket_id = "FDA-2017-E-4282" sorted by posted_date descending

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

posted_year 3

  • 2017 5
  • 2018 3
  • 2019 1

document_type 2

  • Other 7
  • Notice 2

agency_id 1

  • FDA 9
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-E-4282-0014 FDA None FDA-2017-E-4282 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2019-08-05T04:00:00Z 2019 8 2019-08-05T04:00:00Z   2019-08-05T19:36:58Z   0 0 0900006483df7c28
FDA-2017-E-4282-0012 FDA None FDA-2017-E-4282 Determination of Regulatory Review Period for Purposes of Patent Extension; TRULANCE Notice Determinations 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z 2019-02-05T04:59:59Z 2019-01-30T02:05:27Z 2018-26289 0 0 09000064839390a7
FDA-2017-E-4282-0011 FDA None FDA-2017-E-4282 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2018-11-20T05:00:00Z 2018 11 2018-11-20T05:00:00Z   2018-11-20T13:06:21Z   0 0 09000064838eb872
FDA-2017-E-4282-0010 FDA None FDA-2017-E-4282 Letter from the U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2018-10-02T04:00:00Z 2018 10 2018-10-02T04:00:00Z   2018-10-02T13:04:03Z   0 0 090000648378acad
FDA-2017-E-4282-0005 FDA None FDA-2017-E-4282 Letter from FDA CDER to the U.S. Patent and Trademark Office Other Letter(s) 2017-09-21T04:00:00Z 2017 9 2017-09-21T04:00:00Z   2017-09-21T18:48:54Z   0 0 0900006482b6ba26
FDA-2017-E-4282-0003 FDA None FDA-2017-E-4282 Providing Regulatory Submissions in Electronic Format--Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability Notice Notice of Availability 2017-09-05T04:00:00Z 2017 9 2017-09-05T04:00:00Z 2018-03-06T04:59:59Z 2018-03-06T14:01:21Z 2017-18506 0 0 0900006482b0c1cb
FDA-2017-E-4282-0004 FDA None FDA-2017-E-4282 Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format--Content of Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling Other Guidance 2017-09-05T04:00:00Z 2017 9 2017-09-05T04:00:00Z   2024-11-07T01:11:09Z   1 0 0900006482b0c6e5
FDA-2017-E-4282-0001 FDA None FDA-2017-E-4282 Letter from U.S. Patent and Trademark Office to CDER Other Letter(s) 2017-07-18T04:00:00Z 2017 7 2017-07-18T04:00:00Z   2017-07-18T12:05:36Z   0 0 090000648293b0e3
FDA-2017-E-4282-0002 FDA None FDA-2017-E-4282 Patent Extension Application from Cooley LLP (on behalf of Synergy Pharmaceuticals, Inc.) Other Application 2017-07-18T04:00:00Z 2017 7 2017-07-18T04:00:00Z   2017-07-18T12:11:57Z   0 0 090000648293b0df

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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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