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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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14 rows where agency_id = "FDA" and docket_id = "FDA-2011-N-0513" sorted by posted_date descending

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posted_year 2

document_type 2

agency_id 1

  • FDA · 14 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-0513-0017 FDA None FDA-2011-N-0513 FDA/OC/CDER to G. Matthew Warren, Senior Regulatory Counsel, March 30, 2012- Letter Other Letter(s) 2012-04-02T04:00:00Z 2012 4 2012-04-02T04:00:00Z   2012-04-02T13:55:23Z   0 0 0900006480fe5c91
FDA-2011-N-0513-0016 FDA None FDA-2011-N-0513 FDA/OC/CDER to G. Matthew Warren, Senior Regulatory Counsel, February 17, 2012- Letter Other Letter(s) 2012-02-21T05:00:00Z 2012 2 2012-02-21T05:00:00Z   2012-02-21T16:57:50Z   0 0 0900006480fbaca1
FDA-2011-N-0513-0015 FDA None FDA-2011-N-0513 ISTA Pharmaceuticals, Inc. (Covington & Burling, LLP) February 2, 2012 - Letter Other Letter(s) 2012-02-16T05:00:00Z 2012 2 2012-02-16T05:00:00Z   2012-02-21T16:40:27Z   0 0 0900006480fb87df
FDA-2011-N-0513-0012 FDA None FDA-2011-N-0513 Covington & Burling - Letter Other Letter(s) 2012-01-24T05:00:00Z 2012 1 2012-01-24T05:00:00Z   2012-01-24T16:22:50Z   0 0 0900006480f89793
FDA-2011-N-0513-0014 FDA None FDA-2011-N-0513 FDA/OC/CDER to G. Matthew Warren, Senior Regulatory Counsel - Letter Other Letter(s) 2012-01-24T05:00:00Z 2012 1 2012-01-24T05:00:00Z   2012-01-24T16:51:20Z   0 0 0900006480fa2836
FDA-2011-N-0513-0013 FDA None FDA-2011-N-0513 FDA/OC Letter to Parties from the Office of the Commissioner, dated December 30, 2011 - Letter Other Letter(s) 2012-01-24T05:00:00Z 2012 1 2012-01-24T05:00:00Z   2012-01-24T16:27:54Z   0 0 0900006480fa27a9
FDA-2011-N-0513-0011 FDA None FDA-2011-N-0513 ISTA Pharmaceuticals, Inc. (Covington & Burling, LLP) - Letter Other Letter(s) 2012-01-24T05:00:00Z 2012 1 2012-01-24T05:00:00Z   2012-01-24T16:20:10Z   0 0 0900006480f8a7cf
FDA-2011-N-0513-0010 FDA None FDA-2011-N-0513 FDA/OC and ISTA Pharmaceuticals to G. Mathew Warren, FDA Senior Regulatory Counsel, December 16, 2011 - Letter Other Letter(s) 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T17:27:13Z   0 0 0900006480f88124
FDA-2011-N-0513-0009 FDA None FDA-2011-N-0513 FDA/CDER to Margaret A. Hamburg, M.D., FDA Commissioner - Letter Other Letter(s) 2011-12-06T05:00:00Z 2011 12 2011-12-06T05:00:00Z   2011-12-06T14:48:06Z   0 0 0900006480f7c1ae
FDA-2011-N-0513-0008 FDA None FDA-2011-N-0513 FDA/CDER to Margaret A. Hamburg, M.D. , FDA Commissioner - Response to November 7, 2011 Letter Other Response(s) 2011-11-30T05:00:00Z 2011 11 2011-12-01T05:00:00Z   2011-12-01T15:07:48Z   0 0 0900006480f77f33
FDA-2011-N-0513-0007 FDA None FDA-2011-N-0513 FDA/OC to ISTA Pharmaceuticals, Inc. (Covington & Burling LLP) and Staff Attorney - Memo with attached letter Other Memo 2011-11-16T05:00:00Z 2011 11 2011-11-16T05:00:00Z   2011-11-16T21:42:37Z   0 0 0900006480f6df5b
FDA-2011-N-0513-0004 FDA None FDA-2011-N-0513 FDA/OC to Staff Attorneys re: Separation of Functions, September 1, 2011 - Memorandum Other Memorandum 2011-10-13T04:00:00Z 2011 10 2011-10-13T04:00:00Z   2011-12-22T15:56:09Z   0 0 0900006480f51637
FDA-2011-N-0513-0002 FDA None FDA-2011-N-0513 Proposals to Refuse to Approve Supplemental New Drug Applications: Bromday (Bromfenac Ophthalmic Solution), 0.09; Opportunity for Hearing Notice Notice of Opportunity of Hearing 2011-08-03T04:00:00Z 2011 8 2011-08-03T04:00:00Z 2011-10-04T03:59:59Z 2012-03-24T19:36:44Z 2011-19566 0 0 0900006480ed4a69
FDA-2011-N-0513-0001 FDA None FDA-2011-N-0513 FDA/CDER to ISTA Pharmaceuticals, Inc. (Covington & Burling LLP) - Letter Other Letter(s) 2011-07-13T04:00:00Z 2011 7 2011-07-13T04:00:00Z 2011-11-11T04:59:59Z 2011-07-13T18:50:02Z   0 0 0900006480ec14a6

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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;