documents

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

8 rows where docket_id = "FDA-2013-D-0286" 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

document_type 2

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0286-0017 FDA None FDA-2013-D-0286 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants Notice 30 Day Proposed Information Collection 2018-09-11T04:00:00Z 2018 9 2018-09-11T04:00:00Z 2018-10-12T03:59:59Z 2018-09-11T14:09:54Z 2018-19674 0 0 09000064836d3b8c
FDA-2013-D-0286-0016 FDA None FDA-2013-D-0286 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants Notice 60 Day Proposed Information Collection 2018-06-18T04:00:00Z 2018 6 2018-06-18T04:00:00Z 2018-08-18T03:59:59Z 2018-06-18T14:08:14Z 2018-12968 0 0 090000648342494e
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
FDA-2013-D-0286-0001 FDA None FDA-2013-D-0286 Draft Guidance for Industry; Availability: Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants Notice Notice of Availability 2013-04-01T04:00:00Z 2013 4 2013-04-01T04:00:00Z 2013-06-01T03:59:59Z 2013-06-01T01:03:31Z 2013-07445 0 0 09000064812523e8
FDA-2013-D-0286-0002 FDA None FDA-2013-D-0286 Draft Guidance for Industry; Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants Other Guidance 2013-04-01T04:00:00Z 2013 4 2013-04-01T04:00:00Z   2024-11-07T22:51:05Z   1 0 0900006481251e8a

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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;