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withdrawn,object_id FDA-2017-E-6016-0006,FDA,FDA-2017-E-6016,"Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV",Notice,Determinations,2018-12-31T05:00:00Z,2018,12,2018-12-31T05:00:00Z,2019-02-27T04:59:59Z,2019-01-09T02:01:46Z,2018-28221,0,0,09000064839d2140 FDA-2017-E-6017-0006,FDA,FDA-2017-E-6017,"Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV",Notice,Determinations,2018-12-31T05:00:00Z,2018,12,2018-12-31T05:00:00Z,2019-02-27T04:59:59Z,2018-12-31T23:00:56Z,2018-28221,0,0,09000064839d2141 FDA-2017-E-6708-0006,FDA,FDA-2017-E-6708,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT,Notice,Determinations,2018-12-31T05:00:00Z,2018,12,2018-12-31T05:00:00Z,2019-06-27T03:59:59Z,2024-03-07T21:12:00Z,2018-28216,0,0,09000064839d2146 FDA-2015-N-0101-1463,FDA,FDA-2015-N-0101,Meeting Granted Letter from FDA CDER to Cardinal Health,Other,Approval,2018-12-31T05:00:00Z,2018,12,2018-12-31T05:00:00Z,,2018-12-31T22:18:50Z,,0,0,09000064839d240f FDA-2017-E-6701-0006,FDA,FDA-2017-E-6701,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT,Notice,Determinations,2018-12-31T05:00:00Z,2018,12,2018-12-31T05:00:00Z,2019-06-27T03:59:59Z,2024-03-07T21:19:56Z,2018-28216,0,0,09000064839d2147 FDA-2016-P-1962-0006,FDA,FDA-2016-P-1962,"Letter from FDA CDER to Hyman, Phelps, and McNamara, P.C.",Other,Partial Petition Approval and Denial,2018-12-31T05:00:00Z,2018,12,2018-12-31T05:00:00Z,,2018-12-31T22:07:39Z,,0,0,09000064839d2016 FDA-2018-H-4831-0001,FDA,FDA-2018-H-4831,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T13:16:15Z,,0,0,09000064839c9f85 FDA-2018-H-4848-0001,FDA,FDA-2018-H-4848,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T15:43:41Z,,0,0,09000064839cc441 FDA-2018-H-4820-0001,FDA,FDA-2018-H-4820,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T12:38:02Z,,0,0,09000064839c9c63 FDA-2018-H-4840-0001,FDA,FDA-2018-H-4840,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T16:51:50Z,,0,0,09000064839cc8a4 FDA-2018-H-4817-0001,FDA,FDA-2018-H-4817,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T12:20:01Z,,0,0,09000064839c9c19 FDA-2018-H-4822-0001,FDA,FDA-2018-H-4822,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T12:59:16Z,,0,0,09000064839ca125 FDA-2018-H-4852-0001,FDA,FDA-2018-H-4852,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T15:40:52Z,,0,0,09000064839cc629 FDA-2007-D-0369-0459,FDA,FDA-2007-D-0369,"Product-Specific Guidance for Linaclotide; Draft Guidance for Industry",Notice,Notice of Availability,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,2019-02-27T04:59:59Z,2019-02-27T02:04:39Z,2018-28213,0,0,09000064839cbf71 FDA-2018-H-4850-0001,FDA,FDA-2018-H-4850,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T15:33:00Z,,0,0,09000064839cc5da FDA-2018-H-4844-0001,FDA,FDA-2018-H-4844,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T16:40:36Z,,0,0,09000064839cca11 FDA-2018-H-4818-0001,FDA,FDA-2018-H-4818,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T12:25:19Z,,0,0,09000064839c9c34 FDA-2018-H-4855-0001,FDA,FDA-2018-H-4855,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T16:56:09Z,,0,0,09000064839ccbc2 FDA-2018-H-4809-0001,FDA,FDA-2018-H-4809,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T13:32:37Z,,0,0,09000064839c9419 FDA-2018-H-4837-0001,FDA,FDA-2018-H-4837,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T14:12:19Z,,0,0,09000064839cbb58 FDA-2018-H-4830-0001,FDA,FDA-2018-H-4830,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T13:12:50Z,,0,0,09000064839c9c0b FDA-2018-H-4835-0001,FDA,FDA-2018-H-4835,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T13:27:00Z,,0,0,09000064839cb843 FDA-2018-H-4859-0001,FDA,FDA-2018-H-4859,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T15:55:17Z,,0,0,09000064839cc998 FDA-2017-E-6003-0006,FDA,FDA-2017-E-6003,"Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV",Notice,Determinations,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,2019-02-27T04:59:59Z,2018-12-31T21:10:48Z,2018-28221,0,0,09000064839cbe98 FDA-2018-D-4662-0001,FDA,FDA-2018-D-4662,International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV,Notice,Notice of Availability,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,2019-02-27T04:59:59Z,2019-01-14T19:29:13Z,2018-28219,0,0,09000064839cbf33 FDA-2018-N-3037-0002,FDA,FDA-2018-N-3037,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications",Notice,30 Day Proposed Information Collection,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,2019-01-29T04:59:59Z,2019-01-10T02:46:59Z,2018-28252,0,0,09000064839cbd39 FDA-2018-H-4836-0001,FDA,FDA-2018-H-4836,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T14:10:49Z,,0,0,09000064839cc150 FDA-2018-H-4857-0001,FDA,FDA-2018-H-4857,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T17:16:40Z,,0,0,09000064839ccd6d FDA-2018-H-4819-0001,FDA,FDA-2018-H-4819,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T12:27:47Z,,0,0,09000064839c9bca FDA-2018-H-4808-0001,FDA,FDA-2018-H-4808,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T13:31:48Z,,0,0,09000064839c95f2 FDA-2018-H-4821-0001,FDA,FDA-2018-H-4821,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T12:40:14Z,,0,0,09000064839ca0c0 FDA-2018-H-4849-0001,FDA,FDA-2018-H-4849,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T15:28:25Z,,0,0,09000064839cc537 FDA-2017-E-6736-0005,FDA,FDA-2017-E-6736,"Determination of Regulatory Review Period for Purposes of Patent Extension; XERMELO",Notice,Determinations,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,2019-02-27T04:59:59Z,2018-12-31T21:26:53Z,2018-28218,0,0,09000064839cbee3 FDA-2012-N-0197-0005,FDA,FDA-2012-N-0197,"Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Shortages Data Collection System",Notice,Request for Comments,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,2019-02-27T04:59:59Z,2018-12-31T20:58:41Z,2018-28235,0,0,09000064839cbe96 FDA-2017-E-6002-0006,FDA,FDA-2017-E-6002,"Determination of Regulatory Review Period for Purposes of Patent Extension; RUBRACA",Notice,Determinations,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,2019-02-27T04:59:59Z,2018-12-31T21:05:16Z,2018-28217,0,0,09000064839cbe97 FDA-2018-H-4858-0001,FDA,FDA-2018-H-4858,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T17:17:18Z,,0,0,09000064839ccdd9 FDA-2018-H-4856-0001,FDA,FDA-2018-H-4856,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T16:57:22Z,,0,0,09000064839ccbdc FDA-2018-H-4843-0001,FDA,FDA-2018-H-4843,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T16:56:45Z,,0,0,09000064839ccd08 FDA-2012-N-0536-0008,FDA,FDA-2012-N-0536,"Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601",Notice,60 Day Proposed Information Collection,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,2019-02-27T04:59:59Z,2019-07-17T12:49:50Z,2018-28220,0,0,09000064839cc098 FDA-2018-H-4833-0001,FDA,FDA-2018-H-4833,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T13:19:51Z,,0,0,09000064839cb83d FDA-2018-H-4861-0001,FDA,FDA-2018-H-4861,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T16:11:58Z,,0,0,09000064839cca33 FDA-2018-H-4853-0001,FDA,FDA-2018-H-4853,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T15:47:44Z,,0,0,09000064839cc95c FDA-2018-H-4834-0001,FDA,FDA-2018-H-4834,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T13:23:12Z,,0,0,09000064839ca3b1 FDA-2018-H-4854-0001,FDA,FDA-2018-H-4854,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T16:41:22Z,,0,0,09000064839ccb70 FDA-2017-E-6700-0006,FDA,FDA-2017-E-6700,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT,Notice,Determinations,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,2019-06-27T03:59:59Z,2024-03-07T21:04:21Z,2018-28216,0,0,09000064839cbfba FDA-2018-H-4842-0001,FDA,FDA-2018-H-4842,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T16:54:39Z,,0,0,09000064839ccb78 FDA-2018-H-4838-0001,FDA,FDA-2018-H-4838,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T14:13:06Z,,0,0,09000064839cc18d FDA-2018-H-4860-0001,FDA,FDA-2018-H-4860,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T15:56:00Z,,0,0,09000064839cc9cc FDA-2018-H-4810-0001,FDA,FDA-2018-H-4810,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T13:46:22Z,,0,0,09000064839c944d FDA-2018-H-4846-0001,FDA,FDA-2018-H-4846,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T15:30:01Z,,0,0,09000064839cc502 FDA-2018-H-4847-0001,FDA,FDA-2018-H-4847,Complaint,Other,Complaint,2018-12-28T05:00:00Z,2018,12,2018-12-28T05:00:00Z,,2018-12-28T15:33:36Z,,0,0,09000064839cc508 FDA-2018-H-4788-0001,FDA,FDA-2018-H-4788,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:33:57Z,,0,0,09000064839c81e3 FDA-2018-H-4794-0001,FDA,FDA-2018-H-4794,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:50:26Z,,0,0,09000064839c7f4e FDA-2018-H-4791-0001,FDA,FDA-2018-H-4791,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T12:46:32Z,,0,0,09000064839c723d FDA-2018-H-4781-0001,FDA,FDA-2018-H-4781,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T12:51:27Z,,0,0,09000064839c7235 FDA-2018-H-4797-0001,FDA,FDA-2018-H-4797,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T14:06:15Z,,0,0,09000064839c7fdf FDA-2018-H-4803-0001,FDA,FDA-2018-H-4803,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T16:57:22Z,,0,0,09000064839c8cfd FDA-2018-H-4829-0001,FDA,FDA-2018-H-4829,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T20:13:22Z,,0,0,09000064839c9d74 FDA-2017-F-2130-0016,FDA,FDA-2017-F-2130,"Food Additives Permitted in Feed and Drinking Water of Animals; Formic Acid",Rule,Final Rule,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-31T20:44:12Z,2018-27966,0,0,09000064839c8864 FDA-2018-H-4795-0001,FDA,FDA-2018-H-4795,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:57:39Z,,0,0,09000064839c7f54 FDA-2018-H-4799-0001,FDA,FDA-2018-H-4799,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T15:06:54Z,,0,0,09000064839c89ef FDA-2018-H-4824-0001,FDA,FDA-2018-H-4824,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T20:00:22Z,,0,0,09000064839c9ab2 FDA-2018-H-4775-0001,FDA,FDA-2018-H-4775,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T12:56:05Z,,0,0,09000064839c7094 FDA-2018-H-4798-0001,FDA,FDA-2018-H-4798,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T14:09:39Z,,0,0,09000064839c823d FDA-2018-H-4796-0001,FDA,FDA-2018-H-4796,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T14:02:12Z,,0,0,09000064839c7fa8 FDA-2018-H-4786-0001,FDA,FDA-2018-H-4786,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:10:53Z,,0,0,09000064839c6fd5 FDA-2018-H-4784-0001,FDA,FDA-2018-H-4784,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:25:14Z,,0,0,09000064839c6f94 FDA-2018-H-4787-0001,FDA,FDA-2018-H-4787,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:07:56Z,,0,0,09000064839c6fdb FDA-2018-H-4789-0001,FDA,FDA-2018-H-4789,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:51:44Z,,0,0,09000064839c7fd6 FDA-2018-H-4825-0001,FDA,FDA-2018-H-4825,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T20:32:19Z,,0,0,09000064839c9bfc FDA-2018-H-4813-0001,FDA,FDA-2018-H-4813,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T19:05:53Z,,0,0,09000064839c973d FDA-2018-N-1989-0001,FDA,FDA-2018-N-1989,Ranjan Bhandari: Debarment Order,Notice,Statutory Debarment,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-31T20:39:45Z,2018-27951,0,0,09000064839c8820 FDA-2018-H-4762-0001,FDA,FDA-2018-H-4762,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:01:33Z,,0,0,09000064839c6e2c FDA-2018-H-4792-0001,FDA,FDA-2018-H-4792,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T12:49:14Z,,0,0,09000064839c7265 FDA-2018-H-4807-0001,FDA,FDA-2018-H-4807,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T18:10:20Z,,0,0,09000064839c9367 FDA-2018-H-4785-0001,FDA,FDA-2018-H-4785,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:29:51Z,,0,0,09000064839c6fc3 FDA-2018-H-4802-0001,FDA,FDA-2018-H-4802,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T17:06:32Z,,0,0,09000064839c9121 FDA-2018-H-4826-0001,FDA,FDA-2018-H-4826,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T20:44:27Z,,0,0,09000064839c9c2e FDA-2018-H-4793-0001,FDA,FDA-2018-H-4793,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:44:48Z,,0,0,09000064839c7b76 FDA-2018-H-4801-0001,FDA,FDA-2018-H-4801,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T16:52:09Z,,0,0,09000064839c8ea7 FDA-2018-H-4800-0001,FDA,FDA-2018-H-4800,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T15:09:05Z,,0,0,09000064839c8b0c FDA-2018-H-4814-0001,FDA,FDA-2018-H-4814,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T20:18:22Z,,0,0,09000064839c9bd2 FDA-2018-H-4823-0001,FDA,FDA-2018-H-4823,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T21:30:43Z,,0,0,09000064839ca200 FDA-2018-H-4790-0001,FDA,FDA-2018-H-4790,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T13:57:45Z,,0,0,09000064839c822f FDA-2018-H-4806-0001,FDA,FDA-2018-H-4806,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T17:42:35Z,,0,0,09000064839c91d7 FDA-2018-H-4805-0001,FDA,FDA-2018-H-4805,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T17:12:55Z,,0,0,09000064839c9127 FDA-2018-H-4811-0001,FDA,FDA-2018-H-4811,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T17:01:13Z,,0,0,09000064839c8e17 FDA-2018-H-4816-0001,FDA,FDA-2018-H-4816,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T20:25:54Z,,0,0,09000064839c9bdb FDA-2018-H-4828-0001,FDA,FDA-2018-H-4828,Complaint,Other,Complaint,2018-12-27T05:00:00Z,2018,12,2018-12-27T05:00:00Z,,2018-12-27T21:27:43Z,,0,0,09000064839ca11f FDA-2018-N-4428-0001,FDA,FDA-2018-N-4428,"Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application",Notice,60 Day Proposed Information Collection,2018-12-26T05:00:00Z,2018,12,2018-12-26T05:00:00Z,2019-02-26T04:59:59Z,2019-01-10T02:17:47Z,2018-27812,0,0,09000064839c4daf FDA-2018-H-4688-0001,FDA,FDA-2018-H-4688,Complaint,Other,Complaint,2018-12-26T05:00:00Z,2018,12,2018-12-26T05:00:00Z,,2018-12-26T20:59:50Z,,0,0,09000064839c6c73 FDA-2017-D-3001-0235,FDA,FDA-2017-D-3001,"Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.",Notice,Announcement,2018-12-26T05:00:00Z,2018,12,2018-12-26T05:00:00Z,2019-02-12T04:59:59Z,2019-02-27T02:06:18Z,2018-27807,0,0,09000064839c4e5f FDA-2017-E-5040-0006,FDA,FDA-2017-E-5040,"Determination of Regulatory Review Period for Purposes of Patent Extension; ADLYXIN",Notice,Determinations,2018-12-26T05:00:00Z,2018,12,2018-12-26T05:00:00Z,2019-02-26T04:59:59Z,2019-01-10T02:33:03Z,2018-27805,0,0,09000064839c4db3 FDA-2018-H-4782-0001,FDA,FDA-2018-H-4782,Complaint,Other,Complaint,2018-12-26T05:00:00Z,2018,12,2018-12-26T05:00:00Z,,2018-12-26T20:18:56Z,,0,0,09000064839c6a72 FDA-2014-N-1210-3431,FDA,FDA-2014-N-1210,Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses,Rule,Final Rule,2018-12-26T05:00:00Z,2018,12,2018-12-26T05:00:00Z,,2019-01-10T02:12:36Z,2018-27809,0,0,09000064839c4d26 FDA-2018-D-4455-0001,FDA,FDA-2018-D-4455,"Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders; Availability",Notice,Notice of Availability,2018-12-21T05:00:00Z,2018,12,2018-12-21T05:00:00Z,2019-03-22T03:59:59Z,2019-03-23T01:00:52Z,2018-27657,0,0,09000064839be12e FDA-2017-E-3616-0006,FDA,FDA-2017-E-3616,Letter from FDA CDER to U.S. Patent and Trademark Office,Other,Letter(s),2018-12-21T05:00:00Z,2018,12,2018-12-21T05:00:00Z,,2018-12-21T18:23:37Z,,0,0,09000064839c0871 FDA-2016-D-4308-0026,FDA,FDA-2016-D-4308,04 Reference 3 Compliance Program Guidance Manual Chapter 42 Blood and Blood Components Inspection of Licensed and Unlicensed Blood Banks Brokers Reference Laboratories and Contractors,Supporting & Related Material,Background Material,2018-12-21T05:00:00Z,2018,12,,,2018-12-21T14:36:48Z,,0,0,09000064839beb23 FDA-2016-D-4308-0023,FDA,FDA-2016-D-4308,01 RBC Antigen_Reference List,Supporting & Related Material,Background Material,2018-12-21T05:00:00Z,2018,12,,,2018-12-21T14:34:03Z,,0,0,09000064839beb20 FDA-2017-E-5694-0006,FDA,FDA-2017-E-5694,Letter from FDA CDER to U.S. Patent and Trademark Office,Other,Letter(s),2018-12-21T05:00:00Z,2018,12,2018-12-21T05:00:00Z,,2018-12-21T18:17:49Z,,0,0,09000064839c07c8