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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

4 rows where docket_id = "FDA-2018-N-3758" and posted_year = 2022 sorted by posted_date descending

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

document_type 2

  • Notice 2
  • Other 2

posted_year 1

  • 2022 · 4 ✖

agency_id 1

  • FDA 4
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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

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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    withdrawn INTEGER,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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