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withdrawn,object_id FDA-2015-D-2537-0141,FDA,FDA-2015-D-2537,PCPC Additional Comments,Other,Background Material,2017-12-06T05:00:00Z,2017,12,2017-12-06T05:00:00Z,,2017-12-06T13:29:24Z,,0,0,0900006482ce9273 FDA-2015-D-2537-0140,FDA,FDA-2015-D-2537,ISPE Additional Comments,Other,Letter(s),2017-11-03T04:00:00Z,2017,11,2017-11-03T04:00:00Z,,2017-11-03T16:58:11Z,,0,0,0900006482c3fce8 FDA-2015-D-2537-0109,FDA,FDA-2015-D-2537,"Submission of Quality Metrics Data; Revised Draft Guidance for Industry; Extension of Comment Period",Notice,Extension of Comment Period,2017-01-09T05:00:00Z,2017,1,2017-01-09T05:00:00Z,2017-03-28T03:59:59Z,2017-03-28T13:02:48Z,2017-00094,0,0,09000064824529dd FDA-2015-D-2537-0108,FDA,FDA-2015-D-2537,Request to Extend Comment Period from CGA and GAWDA,Other,Request for Extension,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T16:49:10Z,,0,0,090000648243b643 FDA-2015-D-2537-0107,FDA,FDA-2015-D-2537,"Request to Extend Comment Period from Cook Group, Inc.",Other,Request for Extension,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T16:46:19Z,,0,0,090000648243b1a1 FDA-2015-D-2537-0105,FDA,FDA-2015-D-2537,Request to Extend Comment Period from Pharma & Biopharma Outsourcing Association,Other,Electronic Regulation from Form,2016-12-22T05:00:00Z,2016,12,2016-12-22T05:00:00Z,,2016-12-22T20:04:48Z,,0,0,09000064824317b3 FDA-2015-D-2537-0106,FDA,FDA-2015-D-2537,Request to Extend Comment Period from Catalent Pharma Solutions,Other,Request for Extension,2016-12-22T05:00:00Z,2016,12,2016-12-22T05:00:00Z,,2016-12-28T16:46:10Z,,0,0,09000064824321de FDA-2015-D-2537-0104,FDA,FDA-2015-D-2537,Request to Extend Comment Period from Compressed Gas Association and the Gases and Welding Distributors Association,Other,Request for Extension,2016-12-22T05:00:00Z,2016,12,2016-12-22T05:00:00Z,,2016-12-22T20:01:13Z,,0,0,090000648242e6a6 FDA-2015-D-2537-0103,FDA,FDA-2015-D-2537,Request for Extension from International Society for Pharmaceutical Engineering (ISPE),Other,Request for Extension,2016-12-20T05:00:00Z,2016,12,2016-12-20T05:00:00Z,,2016-12-20T19:46:47Z,,0,0,090000648242879c FDA-2015-D-2537-0102,FDA,FDA-2015-D-2537,Request for Extension from Teva Pharmaceutical,Other,Request for Extension,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,,2016-12-19T17:21:45Z,,0,0,090000648241b220 FDA-2015-D-2537-0101,FDA,FDA-2015-D-2537,Request for Extension from Biotechnology Innovation Organization (BIO) et al,Other,Electronic Regulation from Form,2016-12-13T05:00:00Z,2016,12,2016-12-13T05:00:00Z,,2016-12-13T20:04:38Z,,0,0,0900006482401dbb FDA-2015-D-2537-0100,FDA,FDA-2015-D-2537,Request for Extension from Parenteral Drug Association,Other,Request for Extension,2016-12-13T05:00:00Z,2016,12,2016-12-13T05:00:00Z,,2016-12-13T19:59:41Z,,0,0,09000064823f9bda FDA-2015-D-2537-0097,FDA,FDA-2015-D-2537,Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments,Notice,Notice of Availability,2016-11-25T05:00:00Z,2016,11,2016-11-25T05:00:00Z,2017-03-28T03:59:59Z,2017-03-29T01:00:56Z,2016-28332,0,0,09000064823bef38 FDA-2015-D-2537-0098,FDA,FDA-2015-D-2537,Submission of Quality Metrics Data Guidance for Industry,Other,Guidance,2016-11-25T05:00:00Z,2016,11,2016-11-25T05:00:00Z,,2024-11-12T06:17:15Z,,1,0,09000064823bf567 FDA-2015-D-2537-0040,FDA,FDA-2015-D-2537,Report from ISPE - Quality Metrics Initiative Wave 1,Other,Report,2015-11-18T05:00:00Z,2015,11,2015-11-18T05:00:00Z,,2015-11-18T15:19:20Z,,0,0,0900006481d54fe6 FDA-2015-D-2537-0033,FDA,FDA-2015-D-2537,Presentation by Consumer Healthcare Products Association (CHPA) regarding the Quality Metrics Public Meeting,Other,Presentation,2015-10-22T04:00:00Z,2015,10,2015-10-22T04:00:00Z,,2015-10-22T20:50:10Z,,0,0,0900006481ce316e FDA-2015-D-2537-0039,FDA,FDA-2015-D-2537,"Presentation by R. M. Johnson, Parenteral Drug Association (PDA) regarding the Quality Metrics Public Meeting",Other,Presentation,2015-10-22T04:00:00Z,2015,10,2015-10-22T04:00:00Z,,2015-10-22T21:11:49Z,,0,0,0900006481ce3223 FDA-2015-D-2537-0034,FDA,FDA-2015-D-2537,"Presentation by Ashley Boam, FDA/CDER regarding the Quality Metrics Public Meeting",Other,Presentation,2015-10-22T04:00:00Z,2015,10,2015-10-22T04:00:00Z,,2015-10-22T20:48:50Z,,0,0,0900006481ce3173 FDA-2015-D-2537-0035,FDA,FDA-2015-D-2537,"Presentation by Ron Fitzmartin, Ph.D., FDA/CDER regarding the Quality Metrics Public Meeting",Other,Presentation,2015-10-22T04:00:00Z,2015,10,2015-10-22T04:00:00Z,,2015-10-22T20:54:14Z,,0,0,0900006481ce3175 FDA-2015-D-2537-0036,FDA,FDA-2015-D-2537,"Presentation by David Gaugh, R.Ph., GPhA regarding the Quality Metrics Public Meeting",Other,Presentation,2015-10-22T04:00:00Z,2015,10,2015-10-22T04:00:00Z,,2015-10-22T20:58:15Z,,0,0,0900006481ce3220 FDA-2015-D-2537-0031,FDA,FDA-2015-D-2537,"Presentation by Alan Nicholls, Bulk Pharmaceuticals Task Force (BPTF) regarding the Quality Metrics Public Meeting",Other,Presentation,2015-10-22T04:00:00Z,2015,10,2015-10-22T04:00:00Z,,2015-10-22T20:50:29Z,,0,0,0900006481ce2c0e FDA-2015-D-2537-0037,FDA,FDA-2015-D-2537,"Presentation by Priscilla Zawislak, International Pharmaceutical Excipients Council of the Americas (IPEC) regarding the Quality Metrics Public Meeting",Other,Presentation,2015-10-22T04:00:00Z,2015,10,2015-10-22T04:00:00Z,,2015-10-22T21:04:57Z,,0,0,0900006481ce3221 FDA-2015-D-2537-0038,FDA,FDA-2015-D-2537,Presentation by ISPE regarding the Quality Metrics Public Meeting,Other,Presentation,2015-10-22T04:00:00Z,2015,10,2015-10-22T04:00:00Z,,2015-10-22T21:08:02Z,,0,0,0900006481ce3222 FDA-2015-D-2537-0022,FDA,FDA-2015-D-2537,Attachment 1: Quality Metrics re: Comment from ECA Foundation,Supporting & Related Material,Background Material,2015-09-22T04:00:00Z,2015,9,,,2015-09-22T16:08:56Z,,0,0,0900006481c8bcc4 FDA-2015-D-2537-0017,FDA,FDA-2015-D-2537,Attachment 1: Quality Metrics Survey re Comment from ECA Foundation,Supporting & Related Material,Background Material,2015-09-22T04:00:00Z,2015,9,,,2015-09-22T15:38:21Z,,0,0,0900006481c8bcbf FDA-2015-D-2537-0015,FDA,FDA-2015-D-2537,Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Extension of Comment Period,Notice,Extension of Comment Period,2015-08-26T04:00:00Z,2015,8,2015-08-26T04:00:00Z,2015-11-28T04:59:59Z,2015-11-28T22:00:32Z,2015-21149,0,0,0900006481c3a8b4 FDA-2015-D-2537-0010,FDA,FDA-2015-D-2537,Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Correction,Notice,Correction,2015-08-07T04:00:00Z,2015,8,2015-08-07T04:00:00Z,,2015-08-07T13:20:23Z,2015-19487,0,0,0900006481bca608 FDA-2015-D-2537-0009,FDA,FDA-2015-D-2537,Request for Extension from Generic Pharmaceutical Association (GPhA),Other,Request for Extension,2015-08-04T04:00:00Z,2015,8,2015-07-28T04:00:00Z,2015-09-29T03:59:59Z,2015-10-22T19:19:27Z,,0,0,0900006481bbb288 FDA-2015-D-2537-0002,FDA,FDA-2015-D-2537,Request for Quality Metrics Guidance for Industry Draft Guidance,Other,Guidance,2015-07-28T04:00:00Z,2015,7,2015-07-28T04:00:00Z,,2024-11-11T21:07:59Z,,1,0,0900006481baae35 FDA-2015-D-2537-0001,FDA,FDA-2015-D-2537,"Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments",Notice,Notice of Availability,2015-07-28T04:00:00Z,2015,7,2015-07-28T04:00:00Z,2015-09-29T03:59:59Z,2015-09-29T01:30:54Z,2015-18448,0,0,0900006481baa6bd