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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-D-0286" and posted_year = 2015 sorted by posted_date descending

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

document_type 2

  • Notice 3
  • Other 1

posted_year 1

  • 2015 · 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-D-0286-0015 FDA None FDA-2013-D-0286 Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants Guidance for Industry Other Guidance 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:32:01Z   1 0 0900006481d56471
FDA-2013-D-0286-0014 FDA None FDA-2013-D-0286 Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants; Guidance for Industry; Availability Notice Notice of Availability 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2015-11-18T16:29:20Z 2015-29455 0 0 0900006481d54890
FDA-2013-D-0286-0013 FDA None FDA-2013-D-0286 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants Notice Notice of Approval 2015-10-29T04:00:00Z 2015 10 2015-10-29T04:00:00Z   2015-10-29T14:15:19Z 2015-27558 0 0 0900006481cf8adf
FDA-2013-D-0286-0012 FDA None FDA-2013-D-0286 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants Notice 30 Day Proposed Information Collection 2015-06-05T04:00:00Z 2015 6 2015-06-05T04:00:00Z 2015-07-07T03:59:59Z 2015-06-05T15:03:49Z 2015-13695 0 0 0900006481b1ccd1

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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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