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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-2007-D-0369" and posted_year = 2008 sorted by posted_date descending

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Suggested facets: posted_date, posted_month, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 3

  • Other 3
  • Supporting & Related Material 2
  • Notice 1

posted_year 1

  • 2008 · 6 ✖

agency_id 1

  • FDA 6
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2007-D-0369-0018 FDA None FDA-2007-D-0369 Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations Notice NAD-Notice of Availability of Data 2008-09-05T04:00:00Z 2008 9 2008-09-05T04:00:00Z 2008-12-05T04:59:59Z 2008-09-05T13:02:53Z E8-20580 0 0 09000064806f2938
FDA-2007-D-0369-0019 FDA None FDA-2007-D-0369 See FDA-2007-D-0369-0015 Supporting & Related Material GDL-Guidance 2008-09-05T04:00:00Z 2008 9     2024-11-12T04:19:29Z   0 0 09000064806f2c6c
FDA-2007-D-0369-0015 FDA None FDA-2007-D-0369 Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Draft Guidance Document Other Guidance 2008-07-22T04:00:00Z 2008 7 2007-05-31T04:00:00Z   2024-11-01T01:00:56Z   0 0 09000064805f5666
FDA-2007-D-0369-0017 FDA None FDA-2007-D-0369 Medicis Pharmaceutical Corporation - Supplement Other Supplement (SUP) 2008-07-22T04:00:00Z 2008 7 2007-05-30T04:00:00Z 2007-09-29T03:59:59Z 2015-03-13T04:13:40Z   0 0 0900006480469825
FDA-2007-D-0369-0012 FDA None FDA-2007-D-0369 ASTS - Shipping Label Supporting & Related Material BKG-Background Material 2008-04-07T04:00:00Z 2008 4     2008-04-07T23:08:14Z   0 0 0900006480468a0a
FDA-2007-D-0369-0011 FDA None FDA-2007-D-0369 Natco Pharma Limited to Center for Drug Evaluation and Research - Letter Other LET-Letter 2008-04-07T04:00:00Z 2008 4 2008-04-07T04:00:00Z   2013-08-11T04:04:35Z   0 0 090000648042bb8e

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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;
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