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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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13 rows where docket_id = "FDA-2018-N-3758" sorted by posted_date descending

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posted_year 4

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-3758-0015 FDA None FDA-2018-N-3758 Individual Patient Expanded Access Investigational New Drug Application (IND) Other Forms 2022-11-10T05:00:00Z 2022 11 2022-11-10T05:00:00Z   2022-11-10T20:24:32Z   0 0 09000064854a3f42
FDA-2018-N-3758-0014 FDA None FDA-2018-N-3758 INSTRUCTIONS FOR FILLING OUT FORM FDA 3926 – INDIVIDUAL PATIENT EXPANDED ACCESS, INVESTIGATIONAL NEW DRUG APPLICATION (IND) Other Forms 2022-11-10T05:00:00Z 2022 11 2022-11-10T05:00:00Z   2022-11-10T20:23:16Z   0 0 09000064854a4474
FDA-2018-N-3758-0013 FDA None FDA-2018-N-3758 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice Notice of Approval 2022-07-06T04:00:00Z 2022 7 2022-07-06T04:00:00Z   2023-04-27T14:50:33Z 2022-14348 0 0 09000064851b2f1d
FDA-2018-N-3758-0011 FDA None FDA-2018-N-3758 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use Notice 30 Day Proposed Information Collection 2022-04-28T04:00:00Z 2022 4 2022-04-28T04:00:00Z 2022-06-01T03:59:59Z 2023-04-27T14:50:20Z 2022-09070 0 0 090000648503dd7f
FDA-2018-N-3758-0009 FDA None FDA-2018-N-3758 Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use Notice 60 Day Proposed Information Collection 2021-12-14T05:00:00Z 2021 12 2021-12-14T05:00:00Z 2022-02-15T04:59:59Z 2023-04-27T14:49:59Z 2021-26990 0 0 0900006484ec65df
FDA-2018-N-3758-0008 FDA None FDA-2018-N-3758 INSTRUCTIONS FOR FILLING OUT FORM FDA 3926 – INDIVIDUAL PATIENT EXPANDED ACCESS, INVESTIGATIONAL NEW DRUG APPLICATION (IND) Other Forms 2021-12-02T05:00:00Z 2021 12 2021-12-02T05:00:00Z   2021-12-02T16:14:24Z   0 0 0900006484e95bb3
FDA-2018-N-3758-0007 FDA None FDA-2018-N-3758 INDIVIDUAL PATIENT EXPANDED ACCESS, INVESTIGATIONAL NEW DRUG APPLICATION (IND) Other Forms 2021-12-02T05:00:00Z 2021 12 2021-12-02T05:00:00Z   2021-12-02T16:13:06Z   0 0 0900006484e95bb1
FDA-2018-N-3758-0006 FDA None FDA-2018-N-3758 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2019-07-23T04:00:00Z 2019 7 2019-07-23T04:00:00Z   2019-07-23T16:18:17Z 2019-15626 0 0 0900006483dab976
FDA-2018-N-3758-0005 FDA None FDA-2018-N-3758 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Individual Patient Expanded Access Applications Notice 30 Day Proposed Information Collection 2019-04-17T04:00:00Z 2019 4 2019-04-17T04:00:00Z 2019-05-18T03:59:59Z 2019-04-17T14:06:26Z 2019-07711 0 0 0900006483bb2f08
FDA-2018-N-3758-0003 FDA None FDA-2018-N-3758 Attachment 1 - Form FDA 3926 – Individual Patient Expanded Access, Investigational New Drug Application (IND) re: Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926 Supporting & Related Material Background Material 2018-11-14T05:00:00Z 2018 11     2018-11-15T03:25:00Z   0 0 09000064838d8ade
FDA-2018-N-3758-0004 FDA None FDA-2018-N-3758 Attachment 2 - Form Instructions re: Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926 Supporting & Related Material Background Material 2018-11-14T05:00:00Z 2018 11     2018-11-15T03:25:09Z   0 0 09000064838d8adf
FDA-2018-N-3758-0002 FDA None FDA-2018-N-3758 Individual Patient Expanded Access Applications: Form FDA 3926 Guidance for Industry Other Guidance 2018-11-14T05:00:00Z 2018 11 2018-11-14T05:00:00Z   2024-11-12T22:49:51Z   1 0 09000064838d805a
FDA-2018-N-3758-0001 FDA None FDA-2018-N-3758 Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926 Notice 60 Day Proposed Information Collection 2018-11-07T05:00:00Z 2018 11 2018-11-07T05:00:00Z 2019-01-08T04:59:59Z 2018-11-07T15:20:25Z 2018-24321 0 0 09000064838a7b1c

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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;