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236 rows where agency_id = "FDA" and docket_id = "FDA-1995-S-0036" sorted by posted_date descending
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posted_year 17
document_type 3
- Other 206
- Supporting & Related Material 29
- Rule 1
agency_id 1
- FDA · 236 ✖
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 | Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 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 |
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