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

8 rows where docket_id = "FDA-2013-D-0446" sorted by posted_date descending

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Suggested facets: 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 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-D-0446-0025 FDA None FDA-2013-D-0446 Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry Other Guidance 2025-11-17T05:00:00Z 2025 11 2025-11-17T05:00:00Z   2025-11-17T19:59:51Z   1 0 09000064b90857a2
FDA-2013-D-0446-0024 FDA None FDA-2013-D-0446 Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability Notice Notice of Availability 2025-11-17T05:00:00Z 2025 11 2025-11-17T05:00:00Z   2025-11-17T19:38:16Z 2025-19984 0 0 09000064b9085097
FDA-2013-D-0446-0016 FDA None FDA-2013-D-0446 Expanded Access to Investigational Drugs for Treatment Use; Questions and Answers; Guidance for Industry; Revised Draft Guidance Other Guidance 2022-11-04T04:00:00Z 2022 11 2022-11-04T04:00:00Z 2023-01-04T04:59:59Z 2024-11-12T23:46:50Z   1 0 090000648547b9f2
FDA-2013-D-0446-0015 FDA None FDA-2013-D-0446 Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Draft Guidance for Industry; Availability Notice Notice of Availability 2022-11-02T04:00:00Z 2022 11     2022-11-02T13:00:13Z 2022-23785 0 0 090000648547b466
FDA-2013-D-0446-0013 FDA None FDA-2013-D-0446 Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers Other Guidance 2016-06-03T04:00:00Z 2016 6     2022-11-02T13:09:37Z   0 0 090000648200de17
FDA-2013-D-0446-0012 FDA None FDA-2013-D-0446 Expanded Access to Investigational Drugs for Treatment Use- Questions and Answers; Guidance for Industry; Availability Notice Notice of Availability 2016-06-03T04:00:00Z 2016 6 2016-06-03T04:00:00Z   2016-06-03T14:20:52Z 2016-13165 0 0 090000648200d007
FDA-2013-D-0446-0002 FDA None FDA-2013-D-0446 Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use--Questions and Answers Other Guidance 2013-05-09T04:00:00Z 2013 5 2013-05-09T04:00:00Z   2024-11-12T05:15:16Z   1 0 09000064812cd344
FDA-2013-D-0446-0001 FDA None FDA-2013-D-0446 Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use--Questions and Answers; Availability Notice Notice of Availability 2013-05-09T04:00:00Z 2013 5 2013-05-09T04:00:00Z 2013-07-09T03:59:59Z 2014-06-19T01:01:23Z 2013-11005 0 0 09000064812cd343

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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;