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

5 rows where docket_id = "FDA-2018-D-0481" 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 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-D-0481-0011 FDA None FDA-2018-D-0481 Standardized Format for Electronic Submission of Marketing Application Content for the Planning of Bioresearch Monitoring Inspections for Center for Drug Evaluation and Research Submissions; Guidance for Industry; Availability Notice Notice of Availability 2024-12-09T05:00:00Z 2024 12     2024-12-09T14:34:19Z 2024-28807 0 0 0900006486856197
FDA-2018-D-0481-0012 FDA None FDA-2018-D-0481 Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions; Guidance for Industry Other Guidance 2024-12-09T05:00:00Z 2024 12 2024-12-09T05:00:00Z   2024-12-09T14:32:35Z   1 0 090000648685643b
FDA-2018-D-0481-0003 FDA None FDA-2018-D-0481 Technical Specifications-Standardized Format for Electronic Submission of NDA BLA Content for BIMO Other Background Material 2018-02-21T05:00:00Z 2018 2 2018-02-21T05:00:00Z   2018-02-21T14:39:26Z   0 0 0900006482f4d097
FDA-2018-D-0481-0002 FDA None FDA-2018-D-0481 Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions; Guidance for Industry; Draft Guidance Other Guidance 2018-02-21T05:00:00Z 2018 2 2018-02-21T05:00:00Z 2018-04-18T03:59:59Z 2024-12-09T14:32:52Z   0 0 0900006482f4d04b
FDA-2018-D-0481-0001 FDA None FDA-2018-D-0481 Submission of Content Necessary for Bioresearch Monitoring Inspection Planning for the Center of Drug Evaluation and Research; Availability Notice Notice of Availability 2018-02-16T05:00:00Z 2018 2 2018-02-16T05:00:00Z 2018-04-18T03:59:59Z 2018-04-14T01:02:35Z 2018-03236 0 0 0900006482f3897d

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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;