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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-2011-D-0611" and posted_year = 2015 sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, comment_start_date (date)

document_type 2

  • Notice 2
  • Other 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-D-0611-0056 FDA None FDA-2011-D-0611 Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry Other Guidance 2015-05-13T04:00:00Z 2015 5 2015-05-13T04:00:00Z   2019-11-18T16:53:10Z   0 0 0900006481addc66
FDA-2011-D-0611-0055 FDA None FDA-2011-D-0611 Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-05-13T04:00:00Z 2015 5 2015-05-13T04:00:00Z 2015-07-14T03:59:59Z 2015-07-14T01:30:24Z 2015-11528 0 0 0900006481addda4
FDA-2011-D-0611-0054 FDA None FDA-2011-D-0611 Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry Other Guidance 2015-04-30T04:00:00Z 2015 4 2015-04-30T04:00:00Z   2019-11-18T16:52:55Z   0 0 0900006481ac56a1
FDA-2011-D-0611-0053 FDA None FDA-2011-D-0611 Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability Notice Notice of Availability 2015-04-30T04:00:00Z 2015 4 2015-04-30T04:00:00Z   2015-04-30T15:38:03Z 2015-10064 0 0 0900006481ac4d35

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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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