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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-2017-D-6380" sorted by posted_date descending

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

posted_year 2

  • 2017 3
  • 2018 3

document_type 2

  • Notice 3
  • Other 3

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-D-6380-0019 FDA None FDA-2017-D-6380 Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases Guidance for Industry Other Guidance 2018-07-27T04:00:00Z 2018 7 2018-07-27T04:00:00Z   2024-11-07T01:04:06Z   1 0 09000064835699a6
FDA-2017-D-6380-0018 FDA None FDA-2017-D-6380 Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Guidance for Industry; Availability Notice Guidance 2018-07-27T04:00:00Z 2018 7 2018-07-27T04:00:00Z   2018-07-27T16:35:26Z 2018-16027 0 0 09000064835678c5
FDA-2017-D-6380-0005 FDA None FDA-2017-D-6380 Guidance: Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases Notice Request for Comments 2018-01-12T05:00:00Z 2018 1 2018-01-12T05:00:00Z 2018-02-19T04:59:59Z 2018-02-19T02:00:39Z 2018-00418 0 0 0900006482dead2d
FDA-2017-D-6380-0003 FDA None FDA-2017-D-6380 Request for Extension from Pharmaceutical Research and Manufacturers of America (PhRMA) Other Request for Extension 2017-12-26T05:00:00Z 2017 12 2017-12-26T05:00:00Z   2017-12-26T20:04:43Z   0 0 0900006482d50ee2
FDA-2017-D-6380-0002 FDA None FDA-2017-D-6380 Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases Draft Guidance for Industry Other Guidance 2017-12-20T05:00:00Z 2017 12 2017-12-20T05:00:00Z 2018-01-20T04:59:59Z 2024-11-07T01:16:12Z   1 0 0900006482d3f8ae
FDA-2017-D-6380-0001 FDA None FDA-2017-D-6380 Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability Notice Notice of Availability 2017-12-20T05:00:00Z 2017 12 2017-12-20T05:00:00Z 2018-01-20T04:59:59Z 2018-01-20T02:02:49Z 2017-27435 0 0 0900006482d3f50b

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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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