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

16 rows where docket_id = "FDA-2016-N-2462" sorted by posted_date descending

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posted_year 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2016-N-2462-0020 FDA None FDA-2016-N-2462 List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Rule Final Rule 2018-12-11T05:00:00Z 2018 12 2018-12-11T05:00:00Z   2018-12-11T14:28:52Z 2018-26712 0 0 0900006483980a26
FDA-2016-N-2462-0004 FDA None FDA-2016-N-2462 Reference 2 FDA Issues Public Advisory for Trasylol re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:41:49Z   0 0 0900006482337d47
FDA-2016-N-2462-0009 FDA None FDA-2016-N-2462 Reference 7 FDA Requests Marketing Suspension of Trasylol re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:45:00Z   0 0 0900006482337db7
FDA-2016-N-2462-0012 FDA None FDA-2016-N-2462 Reference 10 Fertility and Maternal Health Drugs Advisory Committee re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:46:44Z   0 0 0900006482337dba
FDA-2016-N-2462-0008 FDA None FDA-2016-N-2462 Reference 6 Safety Alerts for Human Medical Products re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:44:38Z   0 0 0900006482337db6
FDA-2016-N-2462-0011 FDA None FDA-2016-N-2462 Reference 9 Parlodel re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:46:10Z   0 0 0900006482337db9
FDA-2016-N-2462-0010 FDA None FDA-2016-N-2462 Reference 8 Manufacturer Removes Remaining Stocks of Trasylol re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:45:23Z   0 0 0900006482337db8
FDA-2016-N-2462-0015 FDA None FDA-2016-N-2462 Reference 13 FDA Drug Safety Communication re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:47:57Z   0 0 090000648233810d
FDA-2016-N-2462-0007 FDA None FDA-2016-N-2462 Reference 5 A Comparison of Aprotinin and Lysine Analogues in High-Risk re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:44:16Z   0 0 0900006482337db5
FDA-2016-N-2462-0013 FDA None FDA-2016-N-2462 Reference 11 FDA Drug Safety Communication re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:47:12Z   0 0 0900006482337dbc
FDA-2016-N-2462-0002 FDA None FDA-2016-N-2462 Reference List for 2015-609 re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:41:00Z   0 0 0900006482337d45
FDA-2016-N-2462-0006 FDA None FDA-2016-N-2462 Reference 4 Mortality Associated With Aprotinin re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:43:45Z   0 0 0900006482337db4
FDA-2016-N-2462-0003 FDA None FDA-2016-N-2462 Reference 1 The Risk Associated with Aprotinin in Cardiac Surgery re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:43:14Z   0 0 0900006482337d46
FDA-2016-N-2462-0005 FDA None FDA-2016-N-2462 Reference 3 Aprotinin during Coronary-Artery Bypass Grafting and Risk of re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:42:39Z   0 0 0900006482337d48
FDA-2016-N-2462-0014 FDA None FDA-2016-N-2462 Reference 12 FDA Drug Safety Communication re Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Supporting & Related Material Background Material 2016-10-21T04:00:00Z 2016 10     2016-10-21T20:47:36Z   0 0 090000648233810c
FDA-2016-N-2462-0001 FDA None FDA-2016-N-2462 Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Proposed Rule Amendment 2016-10-18T04:00:00Z 2016 10 2016-10-18T04:00:00Z 2017-01-04T04:59:59Z 2016-12-29T14:00:42Z 2016-25005 0 0 090000648230f5e5

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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;