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withdrawn,object_id FDA-1995-S-0036-0240,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2026-02-03T05:00:00Z,2026,2,2026-02-03T05:00:00Z,,2026-02-03T22:37:09Z,,0,0,09000064b918e04a FDA-1995-S-0036-0239,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2026-01-20T05:00:00Z,2026,1,2026-01-20T05:00:00Z,,2026-01-20T22:12:04Z,,0,0,09000064b9162562 FDA-1995-S-0036-0238,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2025-10-08T04:00:00Z,2025,10,2025-10-08T04:00:00Z,,2025-10-08T23:02:01Z,,0,0,09000064b8ffd398 FDA-1995-S-0036-0237,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2025-09-11T04:00:00Z,2025,9,2025-09-11T04:00:00Z,,2025-09-11T21:06:24Z,,0,0,09000064b8f65bd9 FDA-1995-S-0036-0236,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2025-07-15T04:00:00Z,2025,7,2025-07-15T04:00:00Z,,2025-07-15T21:02:18Z,,0,0,09000064b8e77d24 FDA-1995-S-0036-0235,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2025-06-02T04:00:00Z,2025,6,2025-06-02T04:00:00Z,,2025-06-02T23:04:44Z,,0,0,09000064b8dce847 FDA-1995-S-0036-0234,FDA,FDA-1995-S-0036,Public Disclosure from CoLabs Medical,Other,Public Disclosure,2025-04-09T04:00:00Z,2025,4,2025-04-09T04:00:00Z,,2025-04-09T18:45:55Z,,0,0,0900006486a80e66 FDA-1995-S-0036-0233,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2025-03-18T04:00:00Z,2025,3,2025-03-21T04:00:00Z,,2025-03-21T10:50:11Z,,0,0,0900006486a14f22 FDA-1995-S-0036-0232,FDA,FDA-1995-S-0036,Public Disclosure from Oregon Health and Science University (OHSU),Other,Public Disclosure,2024-12-05T05:00:00Z,2024,12,2025-03-21T04:00:00Z,,2025-03-21T10:49:54Z,,0,0,090000648684a021 FDA-1995-S-0036-0231,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2024-12-02T05:00:00Z,2024,12,2024-12-02T05:00:00Z,,2024-12-02T17:42:42Z,,0,0,0900006486844190 FDA-1995-S-0036-0230,FDA,FDA-1995-S-0036,Public Disclosure from Vanderbilt University Medical Center,Other,Public Disclosure,2024-11-13T05:00:00Z,2024,11,2024-11-13T05:00:00Z,,2024-11-13T15:09:52Z,,0,0,0900006486812ac4 FDA-1995-S-0036-0229,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2024-08-29T04:00:00Z,2024,8,2024-08-29T04:00:00Z,,2024-08-29T20:31:57Z,,0,0,09000064866b3bee FDA-1995-S-0036-0228,FDA,FDA-1995-S-0036,Public Disclosure from Children’s Hospital of Philadelphia,Other,Public Disclosure,2024-07-25T04:00:00Z,2024,7,2024-07-25T04:00:00Z,,2024-07-25T19:34:43Z,,0,0,0900006486605b01 FDA-1995-S-0036-0227,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2024-05-30T04:00:00Z,2024,5,2024-05-30T04:00:00Z,,2024-05-30T18:51:21Z,,0,0,090000648658c8cb FDA-1995-S-0036-0226,FDA,FDA-1995-S-0036,Public Disclosure from Surgery and Critical Care Medicine University of Pittsburgh,Other,Public Disclosure,2024-01-26T05:00:00Z,2024,1,2024-01-26T05:00:00Z,,2024-01-26T14:09:33Z,,0,0,09000064863c4668 FDA-1995-S-0036-0225,FDA,FDA-1995-S-0036,rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial,Other,Public Disclosure,2023-12-12T05:00:00Z,2023,12,2023-12-12T05:00:00Z,,2023-12-12T15:27:09Z,,0,0,0900006486328f46 FDA-1995-S-0036-0224,FDA,FDA-1995-S-0036,Public Disclosures from University of Pittsburgh,Other,Public Disclosure,2023-11-30T05:00:00Z,2023,11,2023-11-30T05:00:00Z,,2023-11-30T20:08:24Z,,0,0,09000064862c3d7a FDA-1995-S-0036-0223,FDA,FDA-1995-S-0036,Public Disclosure from Boston Children's Hospital,Other,Public Disclosure,2023-11-22T05:00:00Z,2023,11,2023-11-22T05:00:00Z,,2023-11-22T13:48:40Z,,0,0,09000064862a2d7a FDA-1995-S-0036-0221,FDA,FDA-1995-S-0036,"Public Disclosure Agenda from Abiomed, Inc.",Other,Agenda,2023-10-06T04:00:00Z,2023,10,2023-10-06T04:00:00Z,,2023-11-30T19:49:27Z,,0,0,090000648605b4e8 FDA-1995-S-0036-0222,FDA,FDA-1995-S-0036,"Public Disclosures from Abiomed, Inc.",Other,Disclosure of Date and Information,2023-10-06T04:00:00Z,2023,10,2023-10-06T04:00:00Z,,2023-11-30T19:45:00Z,,0,0,090000648605b4ea FDA-1995-S-0036-0220,FDA,FDA-1995-S-0036,"Public Disclosure from Vascular Solutions, LLC",Other,Public Disclosure,2023-06-29T04:00:00Z,2023,6,2023-06-29T04:00:00Z,,2023-06-29T19:34:35Z,,0,0,0900006485c15f30 FDA-1995-S-0036-0219,FDA,FDA-1995-S-0036,"Public Disclosure from Jason L Sperry, MD, MPH",Other,Public Disclosure,2023-06-13T04:00:00Z,2023,6,2023-06-13T04:00:00Z,,2023-06-13T20:47:40Z,,0,0,0900006485b0fb14 FDA-1995-S-0036-0218,FDA,FDA-1995-S-0036,Public Disclosure from Vascular Solutions LLC,Other,Public Disclosure,2023-02-10T05:00:00Z,2023,2,2023-02-10T05:00:00Z,,2023-02-10T14:58:40Z,,0,0,0900006485655781 FDA-1995-S-0036-0217,FDA,FDA-1995-S-0036,"Public Disclosure from Vascular Solutions, LLC",Other,Public Disclosure,2023-02-08T05:00:00Z,2023,2,2023-02-08T05:00:00Z,,2023-02-08T17:27:08Z,,0,0,090000648563fa2c FDA-1995-S-0036-0216,FDA,FDA-1995-S-0036,Submission from Vascular Solutions LLC,Other,Submission of Information,2023-01-25T05:00:00Z,2023,1,2023-01-25T05:00:00Z,,2023-01-25T20:47:48Z,,0,0,090000648560a39d FDA-1995-S-0036-0215,FDA,FDA-1995-S-0036,Public Disclosure from Boston Children's Hospital,Other,Public Disclosure,2022-12-28T05:00:00Z,2022,12,2022-12-28T05:00:00Z,,2022-12-28T21:11:15Z,,0,0,090000648555a7de FDA-1995-S-0036-0214,FDA,FDA-1995-S-0036,Public Disclosure from Vascular Solutions LLC,Other,Public Disclosure,2022-11-10T05:00:00Z,2022,11,2022-11-16T05:00:00Z,2021-05-04T03:59:59Z,2022-11-16T14:41:21Z,,0,0,090000648549e6bd FDA-1995-S-0036-0213,FDA,FDA-1995-S-0036,rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial,Other,Public Disclosure,2022-08-30T04:00:00Z,2022,8,2022-08-30T04:00:00Z,,2022-08-30T20:28:47Z,,0,0,0900006485292bb7 FDA-1995-S-0036-0212,FDA,FDA-1995-S-0036,Public Disclosure from Vascular Solutions LLC,Other,Public Disclosure,2022-08-05T04:00:00Z,2022,8,2022-08-05T04:00:00Z,2022-07-15T03:59:59Z,2025-07-15T19:57:41Z,,0,0,0900006485218ec6 FDA-1995-S-0036-0211,FDA,FDA-1995-S-0036,Public Disclosure from University of Pittsburgh,Other,Public Disclosure,2022-07-06T04:00:00Z,2022,7,2022-07-06T04:00:00Z,,2022-07-06T22:03:53Z,,0,0,09000064851b1efc FDA-1995-S-0036-0210,FDA,FDA-1995-S-0036,Public Disclosure Plan for the Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) Trial,Other,Disclosure of Date and Information,2022-05-11T04:00:00Z,2022,5,2022-05-11T04:00:00Z,,2022-07-06T21:56:24Z,,0,0,090000648506f61c FDA-1995-S-0036-0209,FDA,FDA-1995-S-0036,Relying Institution - Community Consultation & Public Disclosure Plan,Other,Report/Survey,2022-05-03T04:00:00Z,2022,5,2022-05-03T04:00:00Z,,2022-05-03T20:36:41Z,,0,0,090000648504b1a7 FDA-1995-S-0036-0208,FDA,FDA-1995-S-0036,Public Disclosure from Jason L. Sperry Surgery and Critical Care Medicine,Other,Letter(s),2022-04-15T04:00:00Z,2022,4,2022-04-18T04:00:00Z,,2024-11-07T00:37:07Z,,1,0,090000648501e050 FDA-1995-S-0036-0207,FDA,FDA-1995-S-0036,PROMPT BOLUS- POST EFIC REPORT,Other,Background Material,2022-01-02T05:00:00Z,2022,1,2022-01-02T05:00:00Z,,2022-01-02T06:21:24Z,,0,0,0900006484ec1e4b FDA-1995-S-0036-0206,FDA,FDA-1995-S-0036,Boston Children’s Hospital Community Consultation & Public Disclosure Plan,Other,Background Material,2022-01-02T05:00:00Z,2022,1,2022-01-02T05:00:00Z,,2022-01-02T06:19:09Z,,0,0,0900006484ec1d39 FDA-1995-S-0036-0203,FDA,FDA-1995-S-0036,Table of Contents,Other,Background Material,2021-12-13T05:00:00Z,2021,12,2022-01-02T05:00:00Z,,2022-01-02T05:58:23Z,,0,0,0900006484ec1d33 FDA-1995-S-0036-0205,FDA,FDA-1995-S-0036,UPMC Children’s Hospital of Pittsburgh Community Consultation & Public Disclosure Plan,Other,Background Material,2021-12-13T05:00:00Z,2021,12,2022-01-02T05:00:00Z,,2022-01-02T06:12:55Z,,0,0,0900006484ec1d37 FDA-1995-S-0036-0204,FDA,FDA-1995-S-0036,Submission Cover Letter,Other,Background Material,2021-12-13T05:00:00Z,2021,12,2022-01-02T05:00:00Z,,2022-01-02T06:12:00Z,,0,0,0900006484ec1d35 FDA-1995-S-0036-0197,FDA,FDA-1995-S-0036,Table of Contents,Other,Background Material,2021-10-26T04:00:00Z,2021,10,2021-10-26T04:00:00Z,,2021-10-26T17:28:19Z,,0,0,0900006484df8a3b FDA-1995-S-0036-0200,FDA,FDA-1995-S-0036,Community Consultation & Public Disclosure Plan from Baylor College of Medicine,Other,Letter(s),2021-10-26T04:00:00Z,2021,10,2021-10-26T04:00:00Z,,2021-10-26T17:45:24Z,,0,0,0900006484df8a41 FDA-1995-S-0036-0202,FDA,FDA-1995-S-0036,Community Consultation & Public Disclosure Plan FROM Children’s Hospital Los Angeles,Other,Letter(s),2021-10-26T04:00:00Z,2021,10,2021-10-26T04:00:00Z,,2021-10-26T17:50:57Z,,0,0,0900006484df8a45 FDA-1995-S-0036-0198,FDA,FDA-1995-S-0036,Cover Letter,Other,Letter(s),2021-10-26T04:00:00Z,2021,10,2021-10-26T04:00:00Z,,2021-10-26T17:29:28Z,,0,0,0900006484df8a3d FDA-1995-S-0036-0199,FDA,FDA-1995-S-0036,Community Consultation & Public Disclosure Plan from Children’s Wisconsin,Other,Letter(s),2021-10-26T04:00:00Z,2021,10,2021-10-26T04:00:00Z,,2021-10-26T17:41:45Z,,0,0,0900006484df8a3f FDA-1995-S-0036-0201,FDA,FDA-1995-S-0036,"Community Consultation & Public Disclosure Plan from Children’s Medical Center, Dallas/University of Texas, Southwestern",Other,Letter(s),2021-10-26T04:00:00Z,2021,10,2021-10-26T04:00:00Z,,2021-10-26T17:48:13Z,,0,0,0900006484df8a43 FDA-1995-S-0036-0194,FDA,FDA-1995-S-0036,Public Disclosure from The Children’s Hospital of Philadelphia,Other,Public Disclosure,2021-09-24T04:00:00Z,2021,9,2021-09-24T04:00:00Z,,2021-10-01T05:12:29Z,,0,0,0900006484d99c13 FDA-1995-S-0036-0192,FDA,FDA-1995-S-0036,Public Disclosure from The Children’s Hospital of Philadelphia,Other,Public Disclosure,2021-09-24T04:00:00Z,2021,9,2021-09-24T04:00:00Z,,2021-10-01T05:10:18Z,,0,0,0900006484d8e908 FDA-1995-S-0036-0191,FDA,FDA-1995-S-0036,Public Disclosure Report from Beth Israel Deaconess Medical Center,Other,Public Disclosure,2021-09-24T04:00:00Z,2021,9,2021-10-01T04:00:00Z,,2021-10-01T05:05:53Z,,0,0,090000648309ad33 FDA-1995-S-0036-0196,FDA,FDA-1995-S-0036,"Public Disclosure Report from Kelly Hoy, Diffusion Pharmaceuticals Inc. - duplication of FDA-1995-S-0036-0190",Other,Public Disclosure,2021-09-24T04:00:00Z,2021,9,2021-09-24T04:00:00Z,,2021-10-01T05:14:11Z,,0,0,090000648435aaeb FDA-1995-S-0036-0195,FDA,FDA-1995-S-0036,Public Disclosure from The Children’s Hospital of Philadelphia,Other,Public Disclosure,2021-09-24T04:00:00Z,2021,9,2021-10-01T04:00:00Z,,2021-10-01T05:13:02Z,,0,0,0900006484d99c60 FDA-1995-S-0036-0193,FDA,FDA-1995-S-0036,Public Disclosure from The Children’s Hospital of Philadelphia,Other,Public Disclosure,2021-09-24T04:00:00Z,2021,9,2021-09-24T04:00:00Z,,2021-10-01T05:11:56Z,,0,0,0900006484d99bc0 FDA-1995-S-0036-0190,FDA,FDA-1995-S-0036,Re: Prehospital Airway Control Trial (PACT),Supporting & Related Material,Background Material,2021-09-08T04:00:00Z,2021,9,,,2021-09-08T16:04:59Z,,0,0,0900006484d60e22 FDA-1995-S-0036-0189,FDA,FDA-1995-S-0036,University of Michigan Dept of Emergency Medicine End of study and Post-Trial Public Disclosure Report for IDE G160263,Other,Supplement (SUP),2021-06-17T04:00:00Z,2021,6,2021-06-17T04:00:00Z,,2021-06-17T12:58:51Z,,0,0,0900006484b904ec FDA-1995-S-0036-0188,FDA,FDA-1995-S-0036,"Public Disclosure from Scott L. Weiss, MD MSCE",Other,Public Disclosure,2021-05-25T04:00:00Z,2021,5,2021-05-25T04:00:00Z,,2021-05-25T15:35:46Z,,0,0,0900006482ce9ef1 FDA-1995-S-0036-0181,FDA,FDA-1995-S-0036,"ESETT, Neurological Emergencies Treatment Trials (NETT) Network Report of Pre-trial Public Disclosure IND #119,756",Other,Public Disclosure,2021-02-05T05:00:00Z,2021,2,2021-02-05T05:00:00Z,,2021-02-05T14:57:36Z,,0,0,0900006482b19fd4 FDA-1995-S-0036-0180,FDA,FDA-1995-S-0036,"ESETT, Neurological Emergencies Treatment Trials (NETT) & PECARN Networks Summary Report of Community Consultations for Public Disclosure IND #119,756",Other,Public Disclosure,2021-02-05T05:00:00Z,2021,2,2021-02-05T05:00:00Z,,2021-02-05T14:57:28Z,,0,0,0900006482b19b84 FDA-1995-S-0036-0182,FDA,FDA-1995-S-0036,"ESETT, Neurological Emergencies Treatment Trials (NETT) & PECARN Networks Examples of Public Disclosure Materials IND #119,756",Other,Public Disclosure,2021-02-05T05:00:00Z,2021,2,2021-02-05T05:00:00Z,,2021-02-05T14:57:41Z,,0,0,0900006482b19fd6 FDA-1995-S-0036-0183,FDA,FDA-1995-S-0036,"Public Disclosure from Jason L Sperry, MD, MPH",Other,Public Disclosure,2021-02-05T05:00:00Z,2021,2,2021-02-05T05:00:00Z,,2021-02-05T14:57:45Z,,0,0,0900006482b6c6a1 FDA-1995-S-0036-0178,FDA,FDA-1995-S-0036,"Public Disclosure Report from Kelly Hoy, Diffusion Pharmaceuticals Inc",Other,Public Disclosure,2019-09-23T04:00:00Z,2019,9,2019-09-23T04:00:00Z,,2019-09-23T12:37:21Z,,0,0,0900006483d2bc1d FDA-1995-S-0036-0179,FDA,FDA-1995-S-0036,"Public Disclosure Report from Kelly Hoy, Diffusion Pharmaceuticals Inc",Other,Public Disclosure,2019-09-23T04:00:00Z,2019,9,2019-09-23T04:00:00Z,,2019-09-23T12:41:23Z,,0,0,0900006483faba35 FDA-1995-S-0036-0176,FDA,FDA-1995-S-0036,"ESETT, Neurological Emergencies Treatment Trials (NETT) & PECARN Networks Public Disclosure Docket Report IND# 119,756",Other,Public Disclosure,2016-11-23T05:00:00Z,2016,11,2016-11-23T05:00:00Z,,2016-11-26T21:14:52Z,,0,0,09000064823bc263 FDA-1995-S-0036-0177,FDA,FDA-1995-S-0036,"ESETT, Neurological Emergencies Treatment Trials (NETT) Network Summary Report of Public Disclosures IND# 119,756",Other,Public Disclosure,2016-11-23T05:00:00Z,2016,11,2016-11-23T05:00:00Z,,2016-11-26T21:14:58Z,,0,0,09000064823bc294 FDA-1995-S-0036-0175,FDA,FDA-1995-S-0036,"ESETT, Neurological Emergencies Treatment Trials (NETT) & PECARN Networks Summary Report of Community Consultations for Public Disclosure IND# 119,756",Other,Public Disclosure,2016-11-23T05:00:00Z,2016,11,2016-11-23T05:00:00Z,,2016-11-23T16:30:14Z,,0,0,09000064823bc25e FDA-1995-S-0036-0171,FDA,FDA-1995-S-0036,"Annual Report from ProTECT III Emory University School of Medicine Public Disclosure IND 104,188 Report 91",Other,Public Disclosure,2016-10-24T04:00:00Z,2016,10,2016-10-24T04:00:00Z,,2016-10-24T17:30:55Z,,0,0,0900006482337a8c FDA-1995-S-0036-0173,FDA,FDA-1995-S-0036,"Resuscitation Outcomes Consortium (ROC) Milwaukee Site, Public Disclosure for Emergency Research Study of Cardiac Arrest, Report 93",Other,Public Disclosure,2016-10-24T04:00:00Z,2016,10,2016-10-24T04:00:00Z,,2016-10-24T17:31:10Z,,0,0,0900006482337ad9 FDA-1995-S-0036-0174,FDA,FDA-1995-S-0036,"Resuscitation Outcomes Consortium, Mayo Clinic Rochester Minnesota Public Disclosure for Tranexamic Acid, Report 94",Other,Public Disclosure,2016-10-24T04:00:00Z,2016,10,2016-10-24T04:00:00Z,,2016-10-24T17:31:16Z,,0,0,0900006482337c0b FDA-1995-S-0036-0172,FDA,FDA-1995-S-0036,"Resuscitation Outcomes Consortium (ROC), Alabama, Dallas-Forth Worth, Pittsburgh and Portland Sites, Community Consultation and Public Disclosure IND F150505004, Report 92",Other,Public Disclosure,2016-10-24T04:00:00Z,2016,10,2016-10-24T04:00:00Z,,2016-10-24T17:31:03Z,,0,0,0900006482337a90 FDA-1995-S-0036-0170,FDA,FDA-1995-S-0036,"Public Disclosure Material from Resuscitation Outcomes Consortium (ROC) Hennepin County Medical Center, Minneapolis Site re IND 119858 Report 89",Other,Public Disclosure,2016-09-19T04:00:00Z,2016,9,2016-09-19T04:00:00Z,,2016-10-21T19:38:09Z,,0,0,09000064822299f5 FDA-1995-S-0036-0168,FDA,FDA-1995-S-0036,"Public Disclosure Report from Penn Medicine, Hospital of the University of Pennsylvania re IND 110314 Report 87",Other,Report,2016-09-19T04:00:00Z,2016,9,2016-09-19T04:00:00Z,,2016-10-21T19:37:34Z,,0,0,0900006482228931 FDA-1995-S-0036-0169,FDA,FDA-1995-S-0036,Public Disclosure Report from Penn Medicine re IND 110314 Report 88,Other,Report,2016-09-19T04:00:00Z,2016,9,2016-09-19T04:00:00Z,,2016-10-21T19:37:51Z,,0,0,0900006481d6aa20 FDA-1995-S-0036-0163,FDA,FDA-1995-S-0036,"Public Disclosure Report from Resuscitation Outcomes Consortium (ROC) Vancouver, British Columbia Site re IND 119858 - Report 82",Other,Report,2015-10-26T04:00:00Z,2015,10,2015-10-26T04:00:00Z,,2015-10-26T21:17:37Z,,0,0,0900006481cefe2f FDA-1995-S-0036-0165,FDA,FDA-1995-S-0036,Public Disclosure Report from Resuscitation Outcomes Consortium (ROC) Milwaukee Site re IND 119858 - Report 84,Other,Report,2015-10-26T04:00:00Z,2015,10,2015-10-26T04:00:00Z,,2015-10-26T21:17:47Z,,0,0,0900006481cefe31 FDA-1995-S-0036-0162,FDA,FDA-1995-S-0036,Public Disclosure Report from Resuscitation Outcomes Consortium (ROC) Alabama Site re IND 119858 - Report 81,Other,Report,2015-10-26T04:00:00Z,2015,10,2015-10-26T04:00:00Z,,2015-10-26T21:17:33Z,,0,0,0900006481cefe2e FDA-1995-S-0036-0167,FDA,FDA-1995-S-0036,Public Disclosure Report from Resuscitation Outcomes Consortium (ROC) Dallas Site re IND 119858 - Report 86,Other,Report,2015-10-26T04:00:00Z,2015,10,2015-10-26T04:00:00Z,,2015-10-26T21:18:07Z,,0,0,0900006481cefe33 FDA-1995-S-0036-0166,FDA,FDA-1995-S-0036,"Public Disclosure Report from Neurological Emergencies Treatment Trials re IND 104,188 - Report 85",Other,Report,2015-10-26T04:00:00Z,2015,10,2015-10-26T04:00:00Z,,2015-10-26T21:18:03Z,,0,0,0900006481cefe32 FDA-1995-S-0036-0164,FDA,FDA-1995-S-0036,Public Disclosure Report from Resuscitation Outcomes Consortium (ROC) Cincinnati Site re IND 119858 - Report 83,Other,Report,2015-10-26T04:00:00Z,2015,10,2015-10-26T04:00:00Z,,2015-10-26T21:17:43Z,,0,0,0900006481cefe30 FDA-1995-S-0036-0161,FDA,FDA-1995-S-0036,Public Disclosure Report from Resuscitation Outcomes Consortium Houston Site re Tranexamic Acid Report 80,Other,Report,2015-04-21T04:00:00Z,2015,4,2015-04-21T04:00:00Z,,2015-04-21T15:13:08Z,,0,0,0900006481ab145c FDA-1995-S-0036-0157,FDA,FDA-1995-S-0036,Public Disclosure Report from Resuscitation Outcomes Consortium Seattle King County re Tranexemic Acid for Traumatic Brain Injury Report 76,Other,Report,2015-04-21T04:00:00Z,2015,4,2015-04-21T04:00:00Z,,2015-04-21T14:48:43Z,,0,0,0900006481ab0fb5 FDA-1995-S-0036-0159,FDA,FDA-1995-S-0036,Public Disclosure Report from Resuscitation Outcomes Consortium Toronto Site re Tranexamic Acid Report 78,Other,Report,2015-04-21T04:00:00Z,2015,4,2015-04-21T04:00:00Z,,2015-04-21T14:59:14Z,,0,0,0900006481ab145a FDA-1995-S-0036-0158,FDA,FDA-1995-S-0036,Public Disclosure Report from Resuscitation Outcomes Consortium Saint Paul Minnesota Site re Tranexamic Acid Report 77,Other,Report,2015-04-21T04:00:00Z,2015,4,2015-04-21T04:00:00Z,,2015-04-21T14:51:00Z,,0,0,0900006481ab0fb6 FDA-1995-S-0036-0160,FDA,FDA-1995-S-0036,Public Disclosure Report from Resuscitation Outcomes Consortium Portland Site re Tranexamic Acid Report 79,Other,Report,2015-04-21T04:00:00Z,2015,4,2015-04-21T04:00:00Z,,2015-04-21T15:06:41Z,,0,0,0900006481ab145b FDA-1995-S-0036-0156,FDA,FDA-1995-S-0036,Hennepin County Medical Center Emergency Medicine Department pre IND 122444 re Ketamine versus Etomidate for Sedation of ED Patients during RSI Report 75,Other,Report,2015-01-14T05:00:00Z,2015,1,2015-01-14T05:00:00Z,,2015-01-14T13:54:12Z,,0,0,09000064819c79d1 FDA-1995-S-0036-0155,FDA,FDA-1995-S-0036,University of Pennsylvania Medicine re IND 110314 pre AVERT Shock Trial Report 74,Other,Report,2014-11-12T05:00:00Z,2014,11,2014-11-12T05:00:00Z,,2014-11-28T19:48:30Z,,0,0,0900006481928b77 FDA-1995-S-0036-0153,FDA,FDA-1995-S-0036,Securisyn Medical IRB Information Concerning Public Disclosures at Hennepin County Medical Center (HCMC) IDE Number G120223 Report 72,Other,Report,2014-10-24T04:00:00Z,2014,10,2014-10-24T04:00:00Z,,2014-11-28T19:48:03Z,,0,0,09000064818fc0a5 FDA-1995-S-0036-0154,FDA,FDA-1995-S-0036,Virginia Commonwealth University re IND 15910 pre Hospital Use of Plama for Traumatic Hemorrhage (PUPTH) protocol Number HM14813 Report 73,Other,Report,2014-10-24T04:00:00Z,2014,10,2014-10-24T04:00:00Z,,2014-11-28T19:48:17Z,,0,0,09000064818fc0a7 FDA-1995-S-0036-0150,FDA,FDA-1995-S-0036,Neurological Emergencies Treatment trails (NETT) IND 104188 Network Emory University,Other,Report,2014-10-24T04:00:00Z,2014,10,2014-10-24T04:00:00Z,,2014-11-28T19:47:14Z,,0,0,09000064818b4436 FDA-1995-S-0036-0143,FDA,FDA-1995-S-0036,Correspondence from Baroness Lady Sonia McMorris Query,Other,Correspondence,2014-09-11T04:00:00Z,2014,9,2014-09-11T04:00:00Z,,2014-11-28T19:45:39Z,,0,0,09000064818679be FDA-1995-S-0036-0142,FDA,FDA-1995-S-0036,"Neuren Pharmaceuticals Ltd, IND 111724, Site Wayne State University Detroit Receiving and Sinai-Grace Hospitals and The Queen's Medical Center, Honolulu, HI Exception From Informed Consent Requirements For Emergency Research Report 68",Other,Report,2014-09-11T04:00:00Z,2014,9,2014-09-11T04:00:00Z,,2014-11-28T19:45:24Z,,0,0,09000064818679bd FDA-1995-S-0036-0145,FDA,FDA-1995-S-0036,Correspondence from Baroness Lady Sonia McMorris Query Follow-up to Query,Other,Correspondence,2014-09-11T04:00:00Z,2014,9,2014-09-11T04:00:00Z,,2014-11-28T19:46:07Z,,0,0,09000064818679c0 FDA-1995-S-0036-0146,FDA,FDA-1995-S-0036,Correspondence from Baroness Lady Sonia McMorris Query Follow-up,Other,Correspondence,2014-09-11T04:00:00Z,2014,9,2014-09-11T04:00:00Z,,2014-11-28T19:46:20Z,,0,0,09000064818679c3 FDA-1995-S-0036-0147,FDA,FDA-1995-S-0036,Correspondence from Baroness Lady Sonia McMorris Query Follow-up Request,Other,Correspondence,2014-09-11T04:00:00Z,2014,9,2014-09-11T04:00:00Z,,2014-11-28T19:46:33Z,,0,0,090000648186ae53 FDA-1995-S-0036-0144,FDA,FDA-1995-S-0036,Correspondence from Baroness Lady Sonia McMorris Query,Other,Correspondence,2014-09-11T04:00:00Z,2014,9,2014-09-11T04:00:00Z,,2014-11-28T19:45:53Z,,0,0,09000064818679bf FDA-1995-S-0036-0152,FDA,FDA-1995-S-0036,"Ben Taub General Hospital and Baylor College of Medicine, IND 100681, Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury, Public Disclosure Material Report 71",Other,Report,2014-08-25T04:00:00Z,2014,8,2014-10-24T04:00:00Z,,2014-11-28T19:47:50Z,,0,0,0900006481868114 FDA-1995-S-0036-0151,FDA,FDA-1995-S-0036,"Resuscitation Outcomes Consortium (ROC) re IND 110280, Pittsburgh Site Public Disclosure Material Report 70",Other,Report,2014-08-12T04:00:00Z,2014,8,2014-10-24T04:00:00Z,,2014-11-28T19:47:39Z,,0,0,0900006481868113 FDA-1995-S-0036-0149,FDA,FDA-1995-S-0036,"Eunice Kennedy Shriver National Institute of Child Health and Human Development, IND 79,010, Lorazepam, Sites Listed in Abstract, Public Disclosure Material Report 69 Correction Cover Letter re FDA-1995-S-0036-0148",Other,Correspondence,2013-09-27T04:00:00Z,2013,9,2013-09-27T04:00:00Z,,2014-11-28T19:46:58Z,,0,0,09000064818679c2 FDA-1995-S-0036-0148,FDA,FDA-1995-S-0036,"Eunice Kennedy Shriver National Institute of Child Health and Human Development, IND 79,010, Lorazepam, Sites Listed in Abstract, Public Disclosure Material Report 69",Other,Report,2013-09-20T04:00:00Z,2013,9,2014-10-24T04:00:00Z,,2014-11-28T19:46:46Z,,0,0,09000064818679c1 FDA-1995-S-0036-0141,FDA,FDA-1995-S-0036,"University of Texas Health Science Center at Houston, IND 14929, Site Medical College of Wisconsin and Maryland School of Medicine, Public Disclosure Material Report 67 - Report",Other,Report,2013-02-28T05:00:00Z,2013,2,2013-02-28T05:00:00Z,,2014-11-28T19:45:09Z,,0,0,09000064811d19f9 FDA-1995-S-0036-0140,FDA,FDA-1995-S-0036,"ICOS Corporation, Community Consultation and Public Disclosure information for Waiver of Informed Consent, BB IND-7371, Public Disclosure of Study Results - Supplement",Other,Supplement (SUP),2013-01-22T05:00:00Z,2013,1,2013-01-22T05:00:00Z,,2021-02-05T19:06:43Z,,0,0,090000648055b01b FDA-1995-S-0036-0139,FDA,FDA-1995-S-0036,"Baxter, Christiana Hospital, Medical Center of Delaware, INDA#6859, Report 1 - Report",Other,Report,2013-01-22T05:00:00Z,2013,1,2013-01-22T05:00:00Z,,2021-02-05T19:06:42Z,,0,0,090000648055afd1 FDA-1995-S-0036-0138,FDA,FDA-1995-S-0036,"Resuscitation Outcomes Consortium (ROC) re IND 110280, Milwaukee Site Public Disclosure Material Report 66 - Report",Other,Report,2013-01-22T05:00:00Z,2013,1,2013-01-22T05:00:00Z,,2014-11-28T19:44:57Z,,0,0,09000064811bf91d FDA-1995-S-0036-0135,FDA,FDA-1995-S-0036,"Resuscitation Outcomes Consortium (ROC) re IND 110280, British Columbia, Canada Public Disclosure Material Report 63 - Report",Other,Report,2012-12-28T05:00:00Z,2012,12,2012-12-28T05:00:00Z,,2014-11-28T19:44:04Z,,0,0,090000648118f830