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

5 rows where docket_id = "FDA-2015-D-4562" sorted by posted_date descending

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Suggested facets: 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

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-D-4562-0024 FDA None FDA-2015-D-4562 Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction Notice Correction 2017-12-14T05:00:00Z 2017 12 2017-12-14T05:00:00Z   2017-12-14T17:33:45Z 2017-26938 0 0 0900006482d08e78
FDA-2015-D-4562-0022 FDA None FDA-2015-D-4562 Meetings: Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop Notice Announcement 2017-11-27T05:00:00Z 2017 11 2017-11-27T05:00:00Z   2017-11-27T14:49:30Z 2017-25454 0 0 0900006482cae426
FDA-2015-D-4562-0003 FDA None FDA-2015-D-4562 Request for Extension from Biotechnology Innovation Organization (BIO) and Pharmaceutical and Research Manufacturers of America (PhRMA) Other Request for Extension 2016-02-03T05:00:00Z 2016 2 2016-02-03T05:00:00Z   2016-02-03T21:38:43Z   0 0 0900006481e3ba89
FDA-2015-D-4562-0001 FDA None FDA-2015-D-4562 Safety Assessment for Investigational New Drug Application Safety Reporting; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z 2016-02-17T04:59:59Z 2016-02-17T22:01:26Z 2015-31690 0 0 0900006481db6ac5
FDA-2015-D-4562-0002 FDA None FDA-2015-D-4562 Safety Assessment for IND Safety Reporting Guidance for Industry Other Guidance 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z   2024-11-11T21:16:20Z   1 0 0900006481db7079

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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;