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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

16 rows where docket_id = "FDA-2013-D-0575" 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 8

  • 2013 3
  • 2014 3
  • 2017 3
  • 2018 2
  • 2021 2
  • 2016 1
  • 2020 1
  • 2023 1

document_type 2

  • Notice 13
  • Other 3

agency_id 1

  • FDA 16
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-D-0575-0045 FDA None FDA-2013-D-0575 Guidance for Industry; Expedited Programs for Serious Conditions – Drugs and Biologics - Final Guidance Other Guidance 2023-12-01T05:00:00Z 2023 12 2023-12-01T05:00:00Z   2026-01-03T12:40:21Z   1 0 09000064862bd2eb
FDA-2013-D-0575-0044 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2021-05-19T04:00:00Z 2021 5 2021-05-19T04:00:00Z   2021-05-19T14:50:03Z 2021-10535 0 0 0900006484b1b4dc
FDA-2013-D-0575-0042 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expedited Programs for Serious Conditions — Drugs and Biologics Notice 30 Day Proposed Information Collection 2021-02-18T05:00:00Z 2021 2 2021-02-18T05:00:00Z 2021-03-23T03:59:59Z 2021-02-18T15:19:49Z 2021-03244 0 0 0900006484a3c6c3
FDA-2013-D-0575-0040 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions— Drugs and Biologics Notice 60 Day Proposed Information Collection 2020-11-18T05:00:00Z 2020 11 2020-11-18T05:00:00Z 2021-01-20T04:59:59Z 2021-01-21T02:00:41Z 2020-25414 0 0 090000648496582e
FDA-2013-D-0575-0039 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2018-06-08T04:00:00Z 2018 6 2018-06-08T04:00:00Z   2018-06-08T12:42:24Z 2018-12338 0 0 090000648337b835
FDA-2013-D-0575-0037 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and Biologics Notice 30 Day Proposed Information Collection 2018-02-07T05:00:00Z 2018 2 2018-02-07T05:00:00Z 2018-03-10T04:59:59Z 2018-03-15T01:02:49Z 2018-02415 0 0 0900006482ef68c5
FDA-2013-D-0575-0036 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and Biologics Notice 60 Day Proposed Information Collection 2017-11-08T05:00:00Z 2017 11 2017-11-08T05:00:00Z 2018-01-09T04:59:59Z 2017-11-08T15:41:39Z 2017-24296 0 0 0900006482c5836f
FDA-2013-D-0575-0035 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2017-07-03T04:00:00Z 2017 7 2017-07-03T04:00:00Z   2017-07-03T15:56:36Z 2017-13890 0 0 09000064827deed9
FDA-2013-D-0575-0034 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and Biologics Notice 30 Day Proposed Information Collection 2017-03-15T04:00:00Z 2017 3 2017-03-15T04:00:00Z 2017-04-15T03:59:59Z 2017-03-15T15:14:46Z 2017-05104 0 0 0900006482508722
FDA-2013-D-0575-0033 FDA None FDA-2013-D-0575 Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and Biologics Notice 60 Day Proposed Information Collection 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z 2017-01-31T04:59:59Z 2016-11-29T15:05:48Z 2016-28732 0 0 09000064823c5ea9
FDA-2013-D-0575-0031 FDA None FDA-2013-D-0575 Guidance for Industry on Expedited Programs for Serious Conditions— Drugs and Biologics; Availability Notice Notice of Availability 2014-05-30T04:00:00Z 2014 5 2014-05-30T04:00:00Z   2024-11-11T20:53:08Z 2014-12534 1 0 090000648171f1ea
FDA-2013-D-0575-0032 FDA None FDA-2013-D-0575 Guidance for Industry on Expedited Programs for Serious Conditions— Drugs and Biologics Other Guidance 2014-05-30T04:00:00Z 2014 5 2014-05-30T04:00:00Z   2021-05-06T12:58:39Z   0 0 090000648171fab1
FDA-2013-D-0575-0030 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Expedited Programs for Serious Conditions— Drugs and Biologics Notice Notice of Approval 2014-05-01T04:00:00Z 2014 5 2014-05-01T04:00:00Z   2021-02-18T18:08:39Z 2014-09914 0 0 09000064816da49d
FDA-2013-D-0575-0028 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics Notice 30 Day Proposed Information Collection 2013-11-07T05:00:00Z 2013 11 2013-11-07T05:00:00Z 2013-12-10T04:59:59Z 2016-11-04T15:06:21Z 2013-26695 0 0 090000648147285f
FDA-2013-D-0575-0002 FDA None FDA-2013-D-0575 Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics Other Guidance 2013-06-26T04:00:00Z 2013 6 2013-06-26T04:00:00Z   2024-11-12T05:18:57Z   1 0 09000064813419e9
FDA-2013-D-0575-0001 FDA None FDA-2013-D-0575 Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics; Availability Notice Notice of Availability 2013-06-26T04:00:00Z 2013 6 2013-06-26T04:00:00Z 2013-08-27T03:59:59Z 2013-09-05T01:03:53Z 2013-15250 0 0 090000648134164a

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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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