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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-2010-D-0643" sorted by posted_date descending

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

posted_year 3

  • 2012 3
  • 2011 2
  • 2013 2

document_type 2

  • Notice 4
  • Other 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-D-0643-0091 FDA None FDA-2010-D-0643 Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability Notice Notice of Availability 2013-09-18T04:00:00Z 2013 9 2013-09-18T04:00:00Z   2013-09-18T14:10:44Z 2013-22645 0 0 0900006481429cfe
FDA-2010-D-0643-0092 FDA None FDA-2010-D-0643 Guidance for Industry on Electronic Source Data in Clinical Investigations Other Guidance 2013-09-18T04:00:00Z 2013 9 2013-09-18T04:00:00Z   2024-11-11T20:48:23Z   1 0 0900006481429eae
FDA-2010-D-0643-0051 FDA None FDA-2010-D-0643 Draft Guidances for Industry; Availability, etc.: Electronic Source Data in Clinical Investigations; Correction Notice Correction 2012-12-26T05:00:00Z 2012 12 2012-12-26T05:00:00Z   2012-12-26T15:59:59Z 2012-31027 0 0 0900006481199d80
FDA-2010-D-0643-0046 FDA None FDA-2010-D-0643 Draft Guidances for Industry; Electronic Source Data in Clinical Investigations Other Guidance 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z   2019-08-22T19:23:54Z   0 0 090000648116ed80
FDA-2010-D-0643-0045 FDA None FDA-2010-D-0643 Draft Guidances for Industry; Availability: Electronic Source Data in Clinical Investigations Notice Notice of Availability 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z 2013-03-27T03:59:59Z 2013-03-27T02:02:02Z 2012-28198 0 0 090000648116e9b5
FDA-2010-D-0643-0002 FDA None FDA-2010-D-0643 Draft Guidance for Industry Electronic Source Documentation in Clinical Investigations Other GDL-Guidance (Supporting and Related Materials) 2011-01-07T05:00:00Z 2011 1 2011-01-07T05:00:00Z 2011-04-08T03:59:59Z 2019-08-22T19:23:13Z   0 0 0900006480bc6e63
FDA-2010-D-0643-0001 FDA None FDA-2010-D-0643 Draft Guidance for Industry; Availability Electronic Source Documentation in Clinical Investigations Notice Notice of Availability 2011-01-07T05:00:00Z 2011 1 2011-01-07T05:00:00Z 2011-04-08T03:59:59Z 2015-03-24T15:36:00Z 2011-00073 0 0 0900006480bc6d0e

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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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