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36 rows where docket_id = "FDA-2014-D-2175" sorted by posted_date descending
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document_type 3
agency_id 1
- FDA 36
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-D-2175-0041 | FDA | None FDA-2014-D-2175 | Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus Guidance for Industry | Other | Guidance | 2017-01-10T05:00:00Z | 2017 | 1 | 2017-01-10T05:00:00Z | 2024-11-12T06:17:52Z | 1 | 0 | 090000648245701d | ||
| FDA-2014-D-2175-0040 | FDA | None FDA-2014-D-2175 | Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry; Availability | Notice | Notice of Availability | 2017-01-10T05:00:00Z | 2017 | 1 | 2017-01-10T05:00:00Z | 2017-01-10T14:40:59Z | 2017-00200 | 0 | 0 | 0900006482456a50 | |
| FDA-2014-D-2175-0022 | FDA | None FDA-2014-D-2175 | Reference -19 Molecular Evidence of Sexual Transmission of Ebola Virus re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:45:46Z | 0 | 0 | 0900006481d88bb3 | |||
| FDA-2014-D-2175-0024 | FDA | None FDA-2014-D-2175 | Reference 21 - Risk Factors for Zaire Ebolavirus re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:46:39Z | 0 | 0 | 0900006481d88c02 | |||
| FDA-2014-D-2175-0007 | FDA | None FDA-2014-D-2175 | Reference 4 - Horowitz-1992-Solvent detergent-treated plasma: a virus-inactivated substitute for fresh frozen plasma re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:39:29Z | 0 | 0 | 0900006481d83cbc | |||
| FDA-2014-D-2175-0013 | FDA | None FDA-2014-D-2175 | Reference 10 - Ebola Virus Disease in West Africa -The First 9 Months of the Epidemic and Forward Projections re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:41:43Z | 0 | 0 | 0900006481d8405a | |||
| FDA-2014-D-2175-0021 | FDA | None FDA-2014-D-2175 | Reference 18 - CDC-Possible Sexual on of Ebola Virus–Liberia re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:45:23Z | 0 | 0 | 0900006481d84b63 | |||
| FDA-2014-D-2175-0008 | FDA | None FDA-2014-D-2175 | Reference 5 - Robustness of Solvent/Detergent Treatment of Plasma Derivatives: A Data collection from Plasma Protein Therapeutics Association member companies re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:39:55Z | 0 | 0 | 0900006481d83cbd | |||
| FDA-2014-D-2175-0020 | FDA | None FDA-2014-D-2175 | Reference -17 Ebola RNA Persistence in Semen of Ebola Virus Disease Survivors Preliminary Report re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:44:52Z | 0 | 0 | 0900006481d88baf | |||
| FDA-2014-D-2175-0023 | FDA | None FDA-2014-D-2175 | Reference - 20 Leroy_Human Asymptomatic Ebola Infection re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:46:13Z | 0 | 0 | 0900006481d88bfd | |||
| FDA-2014-D-2175-0027 | FDA | None FDA-2014-D-2175 | Reference 24 - Correlates of Immunity to Filovirus Infection re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:47:55Z | 0 | 0 | 0900006481d89163 | |||
| FDA-2014-D-2175-0026 | FDA | None FDA-2014-D-2175 | Reference 23 - Ebola Virus Can Be Effectively Neutralized by Antibody Produced in Natural Human Infection re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:47:27Z | 0 | 0 | 0900006481d8915f | |||
| FDA-2014-D-2175-0032 | FDA | None FDA-2014-D-2175 | Reference 29 - Ebola haemorrhagic fever in Zaire, 1976 re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:49:54Z | 0 | 0 | 0900006481d89352 | |||
| FDA-2014-D-2175-0005 | FDA | None FDA-2014-D-2175 | Reference 2 - Towner-2008-Newly Discovered Ebola virus Associated with Hemorrhagic Fever Outbreak in Uganda re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:38:28Z | 0 | 0 | 0900006481d83cac | |||
| FDA-2014-D-2175-0009 | FDA | None FDA-2014-D-2175 | Reference 6 - Solvent-Detergent Filtered (S/D-F) Fresh Frozen Plasma and Cryoprecipitate Minipools Prepared in a Newly Designed Integral Disposable Processing Bag System re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:40:20Z | 0 | 0 | 0900006481d8411c | |||
| FDA-2014-D-2175-0031 | FDA | None FDA-2014-D-2175 | Reference 28 -Ebola Hemorrhagic Fever: Evaluation of Passive Immunotherapy in Nonhuman Primates re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:49:30Z | 0 | 0 | 0900006481d898d3 | |||
| FDA-2014-D-2175-0017 | FDA | None FDA-2014-D-2175 | Reference 14 - Persistence and Genetic Stability of Ebola Virus during the Outbreak in Kikwit, Democratic Republic of the Congo, 1995 re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:43:24Z | 0 | 0 | 0900006481d84255 | |||
| FDA-2014-D-2175-0006 | FDA | None FDA-2014-D-2175 | Reference 3 Mitchell-1984-Physicochemical Inactivation of Lassa, Ebola, and Marburg Viruses and Effect on Clinical Laboratory Analyses re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:38:57Z | 0 | 0 | 0900006481d83cbb | |||
| FDA-2014-D-2175-0012 | FDA | None FDA-2014-D-2175 | Reference 9 - Incubation Period of Ebola Hemorrhagic Virus Subtype Zaire re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:41:22Z | 0 | 0 | 0900006481d84124 | |||
| FDA-2014-D-2175-0028 | FDA | None FDA-2014-D-2175 | Reference 25 -Successful Treatment of Ebola Virus-Infected Cynomolgus Macaques with Monoclonal Antibodies re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:48:19Z | 0 | 0 | 0900006481d89218 | |||
| FDA-2014-D-2175-0033 | FDA | None FDA-2014-D-2175 | Reference 30 - A Case of Ebola Virus Infection re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:50:22Z | 0 | 0 | 0900006481d89356 | |||
| FDA-2014-D-2175-0004 | FDA | None FDA-2014-D-2175 | Reference 1 - Feldmann-2003-Ebola virus from discovery to vaccine re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:38:07Z | 0 | 0 | 0900006481d83c18 | |||
| FDA-2014-D-2175-0034 | FDA | None FDA-2014-D-2175 | Reference 31- Treatment of Ebola Hemorrhagic Fever with Blood Transfusions from Convalescent Patients re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:50:44Z | 0 | 0 | 0900006481d8937b | |||
| FDA-2014-D-2175-0015 | FDA | None FDA-2014-D-2175 | Reference 12 - Persistence of Ebola Virus in Ocular Fluid during Convalescence re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:42:36Z | 0 | 0 | 0900006481d8424f | |||
| FDA-2014-D-2175-0030 | FDA | None FDA-2014-D-2175 | Reference 27 - Postexposure antibody prophylaxis protects nonhuman primates from filovirus disease re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:49:06Z | 0 | 0 | 0900006481d898cc | |||
| FDA-2014-D-2175-0025 | FDA | None FDA-2014-D-2175 | Reference 22 -Efficacy of Immune Plasma in Treatment of Argentine re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:47:02Z | 0 | 0 | 0900006481d8915d | |||
| FDA-2014-D-2175-0029 | FDA | None FDA-2014-D-2175 | Reference 26 - Delayed treatment of Ebola virus infection with plant-derived monoclonal antibodies provides protection in rhesus macaques re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:48:41Z | 0 | 0 | 0900006481d8921b | |||
| FDA-2014-D-2175-0014 | FDA | None FDA-2014-D-2175 | Reference 11 - On The Quarantine Period For Ebola Virus re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:42:16Z | 0 | 0 | 0900006481d8405e | |||
| FDA-2014-D-2175-0016 | FDA | None FDA-2014-D-2175 | Reference 13 - Assessment of the Risk of Ebola Virus Transmission from Bodily Fluids and Fomites re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:43:00Z | 0 | 0 | 0900006481d84252 | |||
| FDA-2014-D-2175-0003 | FDA | None FDA-2014-D-2175 | Reference List re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:37:31Z | 0 | 0 | 0900006481d83c17 | |||
| FDA-2014-D-2175-0011 | FDA | None FDA-2014-D-2175 | Reference 8 - Inactivation of Viruses in Platelet Concentrates by Photochemical Treatment with Amotosalen and Long-Wavelength Ultraviolet Light re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:41:02Z | 0 | 0 | 0900006481d84122 | |||
| FDA-2014-D-2175-0018 | FDA | None FDA-2014-D-2175 | Reference 15 - Clinical, Virologic, and Immunologic Follow-Up of Convalescent Ebola Hemorrhagic Fever Patients and Their Household Contacts, Kikwit, Democratic Republic of the Congo re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:43:49Z | 0 | 0 | 0900006481d84333 | |||
| FDA-2014-D-2175-0019 | FDA | None FDA-2014-D-2175 | Reference 16 - Unexpected Ebola Virus in a Tertiary Setting: Clinical and Epidemiologic Aspects re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:44:17Z | 0 | 0 | 0900006481d844c9 | |||
| FDA-2014-D-2175-0010 | FDA | None FDA-2014-D-2175 | Reference 7 - Photochemical Treatment of Plasma with Amotosalen and Longwavelength Ultraviolet Light Inactivates Pathogens while Retaining Coagulation Function re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T14:40:40Z | 0 | 0 | 0900006481d8411e | |||
| FDA-2014-D-2175-0002 | FDA | None FDA-2014-D-2175 | Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry | Other | Guidance | 2015-12-03T05:00:00Z | 2015 | 12 | 2015-12-03T05:00:00Z | 2024-11-11T21:15:27Z | 1 | 0 | 0900006481d83b25 | ||
| FDA-2014-D-2175-0001 | FDA | None FDA-2014-D-2175 | Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2015-12-03T05:00:00Z | 2015 | 12 | 2015-12-03T05:00:00Z | 2015-03-03T04:59:59Z | 2015-12-03T15:01:08Z | 2015-30589 | 0 | 0 | 0900006481d82bc1 |
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title TEXT,
document_type TEXT,
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