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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

4 rows where docket_id = "FDA-2013-N-0500" and posted_year = 2018 sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 3
  • Proposed Rule 1

posted_year 1

  • 2018 · 4 ✖

agency_id 1

  • FDA 4
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-0500-0143 FDA None FDA-2013-N-0500 03- Reference 02- U.S. Department of Health and Human Services, Food and Drug Administration, “Fiscal Year 2019 Justification of Estimates for Appropriations Committees Supporting & Related Material Background Material 2018-12-14T05:00:00Z 2018 12     2018-12-14T15:14:01Z   0 0 09000064839949a4
FDA-2013-N-0500-0141 FDA None FDA-2013-N-0500 01-List of References Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Supporting & Related Material Background Material 2018-12-14T05:00:00Z 2018 12     2018-12-14T15:12:24Z   0 0 09000064839949a2
FDA-2013-N-0500-0140 FDA None FDA-2013-N-0500 Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Proposed Rule Withdrawal 2018-12-14T05:00:00Z 2018 12 2018-12-14T05:00:00Z   2018-12-14T14:36:07Z 2018-27098 0 0 09000064839936bc
FDA-2013-N-0500-0142 FDA None FDA-2013-N-0500 02- Reference 01- Draft guidance for industry, “Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn,” Supporting & Related Material Background Material 2018-12-14T05:00:00Z 2018 12     2018-12-14T15:13:06Z   0 0 09000064839949a3

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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    withdrawn INTEGER,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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