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

15 rows where docket_id = "FDA-2009-E-0510" sorted by posted_date descending

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

posted_year 5

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-E-0510-0015 FDA None FDA-2009-E-0510 U.S. Patent and Trademark Office to Novartis - Letter Other Letter(s) 2013-05-07T04:00:00Z 2013 5 2013-05-07T04:00:00Z   2013-05-07T16:31:58Z   0 0 09000064812bdea4
FDA-2009-E-0510-0014 FDA None FDA-2009-E-0510 Notice of Final Determination - Letter Other Letter(s) 2012-12-17T05:00:00Z 2012 12 2012-12-17T05:00:00Z   2012-12-17T17:22:32Z   0 0 090000648118fc0f
FDA-2009-E-0510-0013 FDA None FDA-2009-E-0510 FDA/CDER to U.S. Patent Trademark Office - Letter Other Letter(s) 2011-08-15T04:00:00Z 2011 8 2011-08-15T04:00:00Z   2011-08-15T19:15:47Z   0 0 0900006480ee11a4
FDA-2009-E-0510-0012 FDA None FDA-2009-E-0510 Determination of Regulatory Review Period for Purposes of Patent Extension: COARTEM Notice N-Notice 2010-12-10T05:00:00Z 2010 12 2010-12-10T05:00:00Z   2024-11-07T22:28:12Z 2010-31074 1 0 0900006480bb3967
FDA-2009-E-0510-0011 FDA None FDA-2009-E-0510 U.S. Patent and Trademark Office to the FDA/CDER - Letter Other LET-Letter 2010-04-21T04:00:00Z 2010 4 2010-04-21T04:00:00Z   2013-07-27T23:16:24Z   0 0 0900006480adc3e7
FDA-2009-E-0510-0008 FDA None FDA-2009-E-0510 FDA/CDER to U.S. Patent and Trademark Office - Letter Other LET-Letter 2010-02-18T05:00:00Z 2010 2 2010-02-18T05:00:00Z   2013-07-27T23:08:47Z   0 0 0900006480aa72bb
FDA-2009-E-0510-0010 FDA None FDA-2009-E-0510 Novartis - Supplemental Patent Term Extension Application Other APP-Application 2010-02-18T05:00:00Z 2010 2 2010-02-18T05:00:00Z   2013-07-27T23:04:49Z   0 0 0900006480a80810
FDA-2009-E-0510-0009 FDA None FDA-2009-E-0510 U.S. Patent & Trademark Office to FDA/CDER - Letter Other LET-Letter 2010-02-18T05:00:00Z 2010 2 2010-02-18T05:00:00Z   2013-07-27T23:04:49Z   0 0 0900006480a8080e
FDA-2009-E-0510-0004 FDA None FDA-2009-E-0510 Novartis - Patent Term Extension Application - Appendix B Supporting & Related Material APP-Application 2009-10-16T04:00:00Z 2009 10     2009-10-16T13:53:51Z   0 0 0900006480a43293
FDA-2009-E-0510-0003 FDA None FDA-2009-E-0510 Novartis - Patent Term Extension Application - Appendix A Supporting & Related Material APP-Application 2009-10-16T04:00:00Z 2009 10     2009-10-16T13:53:50Z   0 0 0900006480a43290
FDA-2009-E-0510-0005 FDA None FDA-2009-E-0510 Novartis - Patent Term Extension Application - Appendix C Supporting & Related Material APP-Application 2009-10-16T04:00:00Z 2009 10     2009-10-16T13:53:52Z   0 0 0900006480a43318
FDA-2009-E-0510-0001 FDA None FDA-2009-E-0510 U.S. Patent and Trademark Office to FDA/CDER - Letter Other LET-Letter 2009-10-16T04:00:00Z 2009 10 2009-10-16T04:00:00Z   2009-10-16T13:53:38Z   0 0 0900006480a4328a
FDA-2009-E-0510-0007 FDA None FDA-2009-E-0510 Novartis - Patent Term Extension Application - Appendix E Supporting & Related Material APP-Application 2009-10-16T04:00:00Z 2009 10     2009-10-16T13:53:55Z   0 0 0900006480a4331d
FDA-2009-E-0510-0002 FDA None FDA-2009-E-0510 Novartis - Patent Term Extension Application Other APP-Application 2009-10-16T04:00:00Z 2009 10 2009-10-16T04:00:00Z   2013-07-27T22:57:11Z   0 0 0900006480a4328d
FDA-2009-E-0510-0006 FDA None FDA-2009-E-0510 Novartis - Patent Term Extension Application - Appendix D Supporting & Related Material APP-Application 2009-10-16T04:00:00Z 2009 10     2009-10-16T13:53:53Z   0 0 0900006480a4331b

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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;