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

6 rows where docket_id = "FDA-2018-N-4002" sorted by posted_date descending

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

posted_year 4

document_type 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-4002-0007 FDA None FDA-2018-N-4002 Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council of Harmonisation E2B(R3) Standards; Public Meeting; Request for Comments Notice Public Meetings 2023-02-17T05:00:00Z 2023 2 2023-02-17T05:00:00Z 2023-12-07T04:59:59Z 2023-12-07T02:04:00Z 2023-03372 0 0 09000064856b6f60
FDA-2018-N-4002-0006 FDA None FDA-2018-N-4002 International Council for Harmonization (ICH) E2B(R3) Standards - Transcript 02/19/2020 Other Transcript(s) 2020-07-31T04:00:00Z 2020 7 2020-07-31T04:00:00Z   2020-07-31T21:52:52Z   0 0 09000064847c5ca0
FDA-2018-N-4002-0005 FDA None FDA-2018-N-4002 International Council for Harmonization (ICH) E2B (R3) Standards - Transcript Wednesday, July 17, 2019 Other Transcript(s) 2019-08-26T04:00:00Z 2019 8 2019-08-26T04:00:00Z   2020-08-04T13:43:12Z   0 0 0900006483ec1c13
FDA-2018-N-4002-0003 FDA None FDA-2018-N-4002 Meeting Transcript - Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B (R3) Standards Other Transcript(s) 2019-05-09T04:00:00Z 2019 5 2019-05-09T04:00:00Z   2019-05-09T17:48:40Z   0 0 0900006483c4e958
FDA-2018-N-4002-0002 FDA None FDA-2018-N-4002 Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council for Harmonisation E2B(R3) Standards; Public Meetings; Request for Comments Notice Request for Comments 2019-03-14T04:00:00Z 2019 3 2019-03-14T04:00:00Z 2019-04-26T03:59:59Z 2024-11-12T22:56:38Z 2019-04730 1 0 0900006483ade980
FDA-2018-N-4002-0001 FDA None FDA-2018-N-4002 Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council for Harmonisation E2B(R3) Standards; Public Meetings; Request for Comments Notice Request for Comments 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T15:25:25Z 2018-25063 0 0 09000064838df0b4

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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;