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

4 rows where docket_id = "FDA-2021-D-0368" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2021-D-0368-0012 FDA None FDA-2021-D-0368 Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability Notice Notice of Availability 2025-12-16T05:00:00Z 2025 12 2025-12-16T05:00:00Z   2025-12-16T18:17:17Z 2025-22869 0 0 09000064b90da8c2
FDA-2021-D-0368-0013 FDA None FDA-2021-D-0368 Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards - Final Guidance Other Guidance 2025-12-16T05:00:00Z 2025 12 2025-12-16T05:00:00Z   2026-02-07T13:13:23Z   1 0 09000064b90dcdf0
FDA-2021-D-0368-0001 FDA None FDA-2021-D-0368 Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability Notice Notice of Availability 2021-09-30T04:00:00Z 2021 9 2021-09-30T04:00:00Z 2021-11-30T04:59:59Z 2021-11-30T02:00:39Z 2021-21316 0 0 0900006484db3ae2
FDA-2021-D-0368-0002 FDA None FDA-2021-D-0368 Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices Guidance for Industry DRAFT GUIDANCE Other Guidance 2021-09-30T04:00:00Z 2021 9 2021-09-30T04:00:00Z   2025-12-16T18:37:00Z   0 0 0900006484db408a

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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;