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withdrawn,object_id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,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,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,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for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2015-12-07T05:00:00Z,2015,12,,,2015-12-07T14:45:46Z,,0,0,0900006481d88bb3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,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for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2015-12-07T05:00:00Z,2015,12,,,2015-12-07T14:46:39Z,,0,0,0900006481d88c02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,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for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2015-12-07T05:00:00Z,2015,12,,,2015-12-07T14:39:29Z,,0,0,0900006481d83cbc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,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for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2015-12-07T05:00:00Z,2015,12,,,2015-12-07T14:41:43Z,,0,0,0900006481d8405a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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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