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

6 rows where docket_id = "FDA-2019-D-4964" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2019-D-4964-0009 FDA None FDA-2019-D-4964 Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability; Extension of Comment Period Notice Extension of Comment Period 2020-01-27T05:00:00Z 2020 1 2020-01-27T05:00:00Z   2020-07-28T15:21:43Z 2020-01322 0 0 09000064842f5943
FDA-2019-D-4964-0008 FDA None FDA-2019-D-4964 Request for Extension from Pharmaceutical Research and Manufacturers of America (PhRMA) Other Request for Extension 2020-01-13T05:00:00Z 2020 1 2020-01-13T05:00:00Z   2020-01-13T21:27:59Z   0 0 090000648429340e
FDA-2019-D-4964-0006 FDA None FDA-2019-D-4964 Request for Extension from Biotechnology Innovation Organization (BIO) Other Request for Extension 2019-12-30T05:00:00Z 2019 12 2019-12-30T05:00:00Z   2019-12-30T20:13:53Z   0 0 090000648424d8a8
FDA-2019-D-4964-0003 FDA None FDA-2019-D-4964 Request for Extension from Alliance for Regenerative Medicine Other Request for Extension 2019-12-23T05:00:00Z 2019 12 2019-12-23T05:00:00Z   2019-12-23T16:13:14Z   0 0 09000064842409ad
FDA-2019-D-4964-0001 FDA None FDA-2019-D-4964 Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2019-12-20T05:00:00Z 2019 12 2019-12-20T05:00:00Z 2020-02-19T04:59:59Z 2020-02-23T17:58:48Z 2019-27524 0 0 090000648423ffd2
FDA-2019-D-4964-0002 FDA None FDA-2019-D-4964 Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry DRAFT GUIDANCE Other Guidance 2019-12-20T05:00:00Z 2019 12 2019-12-20T05:00:00Z 2020-03-20T03:59:59Z 2024-11-12T23:14:53Z   1 0 0900006484241d38

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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;