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-2023-D-5259" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2023-D-5259-0009 FDA None FDA-2023-D-5259 Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Extension of Comment Period Notice Extension of Comment Period 2024-02-16T05:00:00Z 2024 2     2024-02-16T13:30:31Z 2024-03296 0 0 090000648640b5dc
FDA-2023-D-5259-0006 FDA None FDA-2023-D-5259 Request for Extension from Pharmaceutical Research and Manufacturers of America (PhRMA) Other Request for Extension 2024-01-18T05:00:00Z 2024 1 2024-01-18T05:00:00Z   2024-01-18T19:15:46Z   0 0 09000064863a441b
FDA-2023-D-5259-0004 FDA None FDA-2023-D-5259 Request for Extension from Biotechnology Innovation Organization (BIO) Other Request for Extension 2024-01-05T05:00:00Z 2024 1 2024-01-05T05:00:00Z   2024-01-05T18:07:09Z   0 0 090000648637b41c
FDA-2023-D-5259-0002 FDA None FDA-2023-D-5259 Master Protocols for Drug and Biological Product Development; Guidance for Industry; Draft Guidance Other Guidance 2023-12-22T05:00:00Z 2023 12 2023-12-22T05:00:00Z 2024-03-22T03:59:59Z 2025-11-19T10:00:06Z   1 0 090000648634c298
FDA-2023-D-5259-0001 FDA None FDA-2023-D-5259 Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability Notice Notice of Availability 2023-12-22T05:00:00Z 2023 12     2023-12-22T15:36:56Z 2023-28210 0 0 0900006486351218

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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;