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

7 rows where docket_id = "FDA-2021-D-0548" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, comment_end_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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0548-0037 FDA None FDA-2021-D-0548 Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry; Final Guidance Other Guidance 2023-12-22T05:00:00Z 2023 12 2023-12-22T05:00:00Z   2024-11-12T06:22:14Z   1 0 090000648634cdc7
FDA-2021-D-0548-0036 FDA None FDA-2021-D-0548 Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry; Availability Notice Notice of Availability 2023-12-22T05:00:00Z 2023 12     2023-12-22T15:08:44Z 2023-28291 0 0 0900006486351145
FDA-2021-D-0548-0035 FDA None FDA-2021-D-0548 Meeting Material from FDA/CDER Other Background Material 2023-04-19T04:00:00Z 2023 4 2023-04-19T04:00:00Z   2023-04-19T17:10:13Z   0 0 0900006485962203
FDA-2021-D-0548-0011 FDA None FDA-2021-D-0548 Data Standards for Drug and BiologicalProduct Submissions Containing Real- World Data; Draft Guidance for Industry; Availability; Extension of Comment Period Notice Extension of Comment Period 2021-12-21T05:00:00Z 2021 12 2021-12-21T05:00:00Z 2022-02-05T04:59:59Z 2022-02-05T02:00:49Z 2021-27521 0 0 0900006484ed8389
FDA-2021-D-0548-0005 FDA None FDA-2021-D-0548 Request to Extension from Pharmaceutical Research and Manufacturers of America (PhRMA) Other Request for Extension 2021-11-05T04:00:00Z 2021 11 2021-11-05T04:00:00Z   2021-11-05T20:15:36Z   0 0 0900006484e25b86
FDA-2021-D-0548-0001 FDA None FDA-2021-D-0548 Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry; Availability Notice Notice of Availability 2021-10-22T04:00:00Z 2021 10 2021-10-22T04:00:00Z 2021-12-22T04:59:59Z 2021-12-22T02:00:13Z 2021-23081 0 0 0900006484de265d
FDA-2021-D-0548-0002 FDA None FDA-2021-D-0548 Data Standards for Drug and Biological Product Submissions Containing Real-World Data Guidance for Industry Other Guidance 2021-10-22T04:00:00Z 2021 10 2021-10-22T04:00:00Z 2022-02-05T04:59:59Z 2023-12-22T15:07:01Z   0 0 0900006484de3a83

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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;