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-2011-D-0436" 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 4

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-D-0436-0030 FDA None FDA-2011-D-0436 International Conference on Harmonisation; Guidance; Q11 Development and Manufacture of Drug Substances Other Guidance 2019-10-21T04:00:00Z 2019 10 2019-10-21T04:00:00Z   2024-11-12T05:09:04Z   1 0 090000648116ed85
FDA-2011-D-0436-0029 FDA None FDA-2011-D-0436 01 Final Guidance for Industry Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and BiotechnologicalBiological Entities) Other Guidance 2018-02-26T05:00:00Z 2018 2 2018-02-26T05:00:00Z   2024-11-07T01:22:26Z   1 0 0900006482f632d2
FDA-2011-D-0436-0028 FDA None FDA-2011-D-0436 Q11 Development and Manufacture of Drug Substances—Questions and Answers (Chemical Entities and Biotechnological/Biological Entities); International Council for Harmonisation; Guidance for Industry; Availability Notice Notice of Availability 2018-02-26T05:00:00Z 2018 2 2018-02-26T05:00:00Z   2018-02-26T16:48:04Z 2018-03809 0 0 0900006482f61eec
FDA-2011-D-0436-0026 FDA None FDA-2011-D-0436 International Conference on Harmonisation; Guidance Availability: Q11 Development and Manufacture of Drug Substances Notice Notice of Availability 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z   2012-11-20T15:21:44Z 2012-28142 0 0 090000648116e95a
FDA-2011-D-0436-0001 FDA None FDA-2011-D-0436 Draft Guidance on Q11 Development and Manufacture of Drug Substances; Availability: International Conference on Harmonisation Notice Notice of Availability 2011-06-29T04:00:00Z 2011 6 2011-06-29T04:00:00Z 2011-09-02T03:59:59Z 2011-06-29T16:56:50Z 2011-16255 0 0 0900006480eb650e
FDA-2011-D-0436-0002 FDA None FDA-2011-D-0436 Q11 Development and Manufacture of Drug Substances; International Conference on Harmonisation - Draft Guidance Other Guidance 2011-06-29T04:00:00Z 2011 6 2011-06-29T04:00:00Z   2019-08-21T18:36:13Z   0 0 0900006480eb66f1

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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;