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-2013-D-1630" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-D-1630-0010 FDA None FDA-2013-D-1630 Guidance on Qualification of Biomarker—Galactomannan in Studies of Treatments of Invasive Aspergillosis; Guidance for Industry Other Guidance 2015-11-13T05:00:00Z 2015 11 2015-11-13T05:00:00Z   2024-11-07T23:35:31Z   1 0 0900006481d40a1d
FDA-2013-D-1630-0009 FDA None FDA-2013-D-1630 Guidance on Qualification of Biomarker—Galactomannan in Studies of Treatments of Invasive Aspergillosis; Guidance for Industry; Availability Notice Notice of Availability 2015-11-13T05:00:00Z 2015 11 2015-11-13T05:00:00Z 2016-01-13T04:59:59Z 2016-01-13T22:00:55Z 2015-28804 0 0 0900006481d3f8ea
FDA-2013-D-1630-0007 FDA None FDA-2013-D-1630 Draft Guidance for Industry on Qualification for the Use of Galactomannan in Serum and Bronchoalveolar Lavage Fluid; Availability Notice Notice of Availability 2014-10-27T04:00:00Z 2014 10 2014-10-27T04:00:00Z 2014-12-27T04:59:59Z 2015-10-15T18:28:52Z 2014-25532 0 0 09000064818feee7
FDA-2013-D-1630-0008 FDA None FDA-2013-D-1630 Draft Guidance for Industry on Qualification for the Use of Galactomannan in Serum and Bronchoalveolar Lavage Fluid Other Guidance 2014-10-27T04:00:00Z 2014 10 2014-10-27T04:00:00Z   2024-11-07T23:09:40Z   1 0 09000064818ff0ae
FDA-2013-D-1630-0001 FDA None FDA-2013-D-1630 Draft Guidance for Industry on Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease; Availability Notice Notice of Availability 2014-01-10T05:00:00Z 2014 1 2014-01-10T05:00:00Z 2014-04-11T03:59:59Z 2020-04-27T19:25:04Z 2014-00259 0 0 09000064814fa97f
FDA-2013-D-1630-0002 FDA None FDA-2013-D-1630 Guidance on Qualification Process for Drug Development Tools Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease Other Guidance 2014-01-10T05:00:00Z 2014 1 2014-01-10T05:00:00Z   2024-11-07T23:02:18Z   1 0 09000064814fc520

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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;