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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-2011-D-0720" sorted by posted_date descending

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

posted_year 3

  • 2011 3
  • 2014 2
  • 2022 2

document_type 2

  • Other 4
  • Notice 3

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-D-0720-0007 FDA None FDA-2011-D-0720 Guidance for Industry; E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide – Data Elements and Message Specification Other Guidance 2022-05-03T04:00:00Z 2022 5 2022-05-03T04:00:00Z   2024-11-07T00:38:57Z   1 0 0900006485049722
FDA-2011-D-0720-0008 FDA None FDA-2011-D-0720 Guidance for Industry; Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide; Backwards and Forwards Compatibility Other Guidance 2022-05-03T04:00:00Z 2022 5 2022-05-03T04:00:00Z   2024-11-07T00:38:57Z   1 0 0900006485049743
FDA-2011-D-0720-0006 FDA None FDA-2011-D-0720 International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility Other Guidance 2014-02-28T05:00:00Z 2014 2 2014-02-28T05:00:00Z   2024-11-11T20:49:32Z   1 0 09000064815eb973
FDA-2011-D-0720-0005 FDA None FDA-2011-D-0720 International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability Notice Notice of Availability 2014-02-21T05:00:00Z 2014 2 2014-02-21T05:00:00Z   2014-02-21T16:21:32Z 2014-03677 0 0 09000064815994c1
FDA-2011-D-0720-0003 FDA None FDA-2011-D-0720 International Conference on Harmonisation: Electronic Transmission of Individual Case Safety Reports, etc., Correction Notice General Notice 2011-11-16T05:00:00Z 2011 11 2011-11-16T05:00:00Z   2011-11-16T22:41:14Z 2011-29485 0 0 0900006480f6d72d
FDA-2011-D-0720-0002 FDA None FDA-2011-D-0720 Draft guidance E2 B (R3) Electronic Transmission of Individual Case Safety Report (ICSRs) Implementation Guide ---- Data Elements and Message Specification Other Guidance 2011-10-20T04:00:00Z 2011 10 2011-10-20T04:00:00Z   2024-11-12T05:03:33Z   1 0 0900006480f567b0
FDA-2011-D-0720-0001 FDA None FDA-2011-D-0720 Draft Guidance on Implementation; Availability: E2B(R3) Electronic Transmission of Individual Case Safety Reports, etc. Notice Notice of Availability 2011-10-20T04:00:00Z 2011 10 2011-10-20T04:00:00Z 2012-01-19T04:59:59Z 2011-10-20T19:42:47Z 2011-27147 0 0 0900006480f56bb8

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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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