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withdrawn,object_id FDA-2014-N-1168-0043,FDA,FDA-2014-N-1168,Appendix A: IMMS Results re: Comment from Teva Pharmaceutical Industries Ltd,Supporting & Related Material,Background Material,2015-07-14T04:00:00Z,2015,7,,,2015-07-14T18:21:54Z,,0,0,0900006481b842cd FDA-2014-N-1168-0044,FDA,FDA-2014-N-1168,Appendix B: Attachments and Tables re: Comment from Teva Pharmaceutical Industries Ltd,Supporting & Related Material,Background Material,2015-07-14T04:00:00Z,2015,7,,,2015-07-14T18:24:32Z,,0,0,0900006481b842ce FDA-2014-N-1168-0042,FDA,FDA-2014-N-1168,Attachment 1 Executive Summary re: Comment from Teva Pharmaceutical Industries Ltd,Supporting & Related Material,Background Material,2015-07-14T04:00:00Z,2015,7,,,2015-07-14T18:20:44Z,,0,0,0900006481b842cc FDA-2014-N-1168-0030,FDA,FDA-2014-N-1168,"Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments",Proposed Rule,Request for Comment,2015-03-05T05:00:00Z,2015,3,2015-03-05T05:00:00Z,2015-06-27T03:59:59Z,2015-07-15T01:31:03Z,2015-05018,0,0,0900006481a2e176 FDA-2014-N-1168-0029,FDA,FDA-2014-N-1168,Generic Drug User Fee Amendments of 2012; September 2014 Public Hearing on Policy Development; Reopening of Docket; Request for Comments,Notice,Request for Comments,2015-02-06T05:00:00Z,2015,2,2015-02-06T05:00:00Z,2015-03-10T03:59:59Z,2015-03-10T02:02:54Z,2015-02401,0,0,09000064819f7e42 FDA-2014-N-1168-0028,FDA,FDA-2014-N-1168,"Transcript Text Version re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014, FDA-2014-N-1168-0026 and FDA-2014-N-1168-0027",Supporting & Related Material,Transcript(s),2015-01-22T05:00:00Z,2015,1,,,2015-01-22T21:33:34Z,,0,0,09000064819d9e78 FDA-2014-N-1168-0026,FDA,FDA-2014-N-1168,"Transcript Part 1 re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014",Other,Transcript(s),2015-01-22T05:00:00Z,2015,1,2015-01-22T05:00:00Z,,2015-01-22T21:25:10Z,,0,0,09000064819d9e76 FDA-2014-N-1168-0027,FDA,FDA-2014-N-1168,"Transcript Part 2 re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014",Other,Transcript(s),2015-01-22T05:00:00Z,2015,1,2015-01-22T05:00:00Z,,2015-01-22T21:25:17Z,,0,0,09000064819d9e77 FDA-2014-N-1168-0025,FDA,FDA-2014-N-1168,Testimony from Marcie Coates re Comment from Mylan Inc.,Supporting & Related Material,Background Material,2014-12-02T05:00:00Z,2014,12,,,2014-12-02T16:52:24Z,,0,0,090000648193a933 FDA-2014-N-1168-0008,FDA,FDA-2014-N-1168,"Slide Presentation from IPEC re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014",Other,Presentation,2014-09-19T04:00:00Z,2014,9,2014-09-19T04:00:00Z,,2014-09-19T17:44:37Z,,0,0,090000648187f826 FDA-2014-N-1168-0009,FDA,FDA-2014-N-1168,"Slide Presentation from TEVA Pharmaceuticals, USA re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014",Other,Presentation,2014-09-19T04:00:00Z,2014,9,2014-09-19T04:00:00Z,,2014-09-19T17:45:03Z,,0,0,090000648187f827 FDA-2014-N-1168-0007,FDA,FDA-2014-N-1168,"Slide Presentation from PureTek Corporation re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014",Other,Presentation,2014-09-19T04:00:00Z,2014,9,2014-09-19T04:00:00Z,,2014-09-19T17:43:02Z,,0,0,090000648187f7ed FDA-2014-N-1168-0010,FDA,FDA-2014-N-1168,"Slide Presentation from GPhA (Generic Pharmaceutical Association) re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014",Other,Presentation,2014-09-19T04:00:00Z,2014,9,2014-09-19T04:00:00Z,,2014-09-19T17:43:44Z,,0,0,090000648187f825 FDA-2014-N-1168-0006,FDA,FDA-2014-N-1168,"Slide Presentation from Perrigo re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014",Other,Presentation,2014-09-19T04:00:00Z,2014,9,2014-09-19T04:00:00Z,,2014-09-19T17:21:45Z,,0,0,090000648187f7ec FDA-2014-N-1168-0002,FDA,FDA-2014-N-1168,"Agenda re Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development September 17, 2014",Other,Agenda,2014-09-16T04:00:00Z,2014,9,2014-09-16T04:00:00Z,,2014-09-16T22:42:18Z,,0,0,0900006481875a1f FDA-2014-N-1168-0001,FDA,FDA-2014-N-1168,"Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development; Request for Comments",Proposed Rule,Notice of Hearing,2014-08-19T04:00:00Z,2014,8,2014-08-19T04:00:00Z,2014-10-14T03:59:59Z,2014-11-21T03:02:42Z,2014-19632,0,0,090000648182f82d