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-2019-D-1828" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1828-0009 FDA None FDA-2019-D-1828 E19 A SELECTIVE APPROACH TO SAFETY DATA COLLECTION IN SPECIFIC LATE-STAGE PREAPPROVAL OR POST-APPROVAL CLINICAL TRIALS Other Guidance 2022-12-06T05:00:00Z 2022 12 2022-12-06T05:00:00Z   2025-07-24T09:00:23Z   1 0 090000648551c1c7
FDA-2019-D-1828-0008 FDA None FDA-2019-D-1828 E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability Notice Notice of Availability 2022-12-06T05:00:00Z 2022 12 2022-12-06T05:00:00Z   2022-12-06T13:19:55Z 2022-26433 0 0 090000648551e24f
FDA-2019-D-1828-0001 FDA None FDA-2019-D-1828 E19 Optimisation of Safety Data Collection; International Council for Harmonisation; Draft Guidance for Industry; Availability Notice Notice of Availability 2019-06-27T04:00:00Z 2019 6 2019-06-27T04:00:00Z 2019-09-26T03:59:59Z 2019-09-26T01:05:09Z 2019-13702 0 0 0900006483d46dc0
FDA-2019-D-1828-0002 FDA None FDA-2019-D-1828 Draft Guidance for Industry E19 Optimisation of Safety Data Collection Other   2019-06-27T00:00:00Z 2019 6     2024-11-12T23:02:41Z   0 1 0900006483d474c1
FDA-2019-D-1828-0003 FDA None FDA-2019-D-1828 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; ICH Harmonised Guidelin; E19 Optimisation of Safety Data Collection Other Guidance 2019-06-26T04:00:00Z 2019 6 2019-06-26T04:00:00Z   2022-12-06T13:33:09Z   0 0 0900006483db1bd3

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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;