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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

5 rows where docket_id = "FDA-2017-D-5928" 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 3

  • 2017 2
  • 2018 2
  • 2022 1

document_type 2

  • Other 3
  • Notice 2

agency_id 1

  • FDA 5
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-5928-0009 FDA None FDA-2017-D-5928 Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA; Guidance for Industry - Revision 1 Other Guidance 2022-10-05T04:00:00Z 2022 10 2022-10-05T04:00:00Z   2024-11-07T01:32:51Z   1 0 09000064853bac1b
FDA-2017-D-5928-0008 FDA None FDA-2017-D-5928 Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry Other Guidance 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z   2022-10-05T19:14:56Z   0 0 090000648390cf2c
FDA-2017-D-5928-0007 FDA None FDA-2017-D-5928 Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments; Guidance for Industry; Availability Notice Notice of Availability 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z   2022-10-05T19:15:10Z 2018-26285 0 0 0900006483939624
FDA-2017-D-5928-0001 FDA None FDA-2017-D-5928 Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability Notice Notice of Availability 2017-10-16T04:00:00Z 2017 10 2017-10-16T04:00:00Z 2017-12-16T04:59:59Z 2017-12-16T02:02:44Z 2017-22288 0 0 0900006482bcd99e
FDA-2017-D-5928-0002 FDA None FDA-2017-D-5928 Guidance for Industry on Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA Other Guidance 2017-10-16T04:00:00Z 2017 10 2017-10-16T04:00:00Z   2024-11-07T01:18:52Z   1 0 0900006482bcddde

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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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