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withdrawn,object_id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-2020-D-1137-0120,FDA,FDA-2020-D-1137,Development and Licensure of Vaccines To Prevent COVID–19; Guidance for Industry; Availability,Notice,Notice of Availability,2023-10-20T04:00:00Z,2023,10,2023-10-20T04:00:00Z,,2023-10-20T15:14:26Z,2023-23162,0,0,09000064861132e0
FDA-2020-D-1137-0121,FDA,FDA-2020-D-1137,Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry,Other,Guidance,2023-10-20T04:00:00Z,2023,10,2023-10-20T04:00:00Z,,2025-08-29T09:00:27Z,,1,0,0900006486114f60
FDA-2020-D-1137-0119,FDA,FDA-2020-D-1137,Guidance Documents Related to Coronavirus Disease 2019 (COVID–19),Notice,General Notice,2023-03-13T04:00:00Z,2023,3,2023-03-13T04:00:00Z,,2023-03-13T14:30:04Z,2023-05094,0,0,090000648579c133
FDA-2020-D-1137-0118,FDA,FDA-2020-D-1137,"Guidance Documents Related to
Coronavirus Disease 2019; Availability",Notice,Notice of Availability,2022-04-22T04:00:00Z,2022,4,2022-04-22T04:00:00Z,,2022-04-25T03:50:54Z,2022-08564,0,0,090000648502d74a
FDA-2020-D-1137-0114,FDA,FDA-2020-D-1137,Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry,Other,Guidance,2022-03-31T04:00:00Z,2022,3,2022-03-31T04:00:00Z,,2022-04-25T03:47:04Z,,0,0,0900006484ff005c
FDA-2020-D-1137-0111,FDA,FDA-2020-D-1137,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2022-01-21T05:00:00Z,2022,1,2022-01-21T05:00:00Z,,2022-04-25T03:47:44Z,2022-01146,0,0,0900006484f2cfeb
FDA-2020-D-1137-0112,FDA,FDA-2020-D-1137,Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency; Guidance for Industry and Health Care Professionals,Other,Guidance,2022-01-21T05:00:00Z,2022,1,2022-01-21T05:00:00Z,,2024-11-07T00:36:13Z,,1,0,0900006484f2d2c6
FDA-2020-D-1137-0110,FDA,FDA-2020-D-1137,Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency,Other,Guidance,2021-12-13T05:00:00Z,2021,12,2021-12-13T05:00:00Z,,2024-11-12T23:35:10Z,,1,0,0900006484ec1526
FDA-2020-D-1137-0103,FDA,FDA-2020-D-1137,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2021-07-23T04:00:00Z,2021,7,2021-07-23T04:00:00Z,,2021-07-23T15:15:46Z,2021-15649,0,0,0900006484c0aa4d
FDA-2020-D-1137-0099,FDA,FDA-2020-D-1137,Emergency Use Authorization for  Vaccines to Prevent COVID-19,Other,Guidance,2021-06-04T04:00:00Z,2021,6,2021-06-04T04:00:00Z,,2022-04-25T03:46:42Z,,0,0,0900006484b56371
FDA-2020-D-1137-0098,FDA,FDA-2020-D-1137,Emergency Use Authorization for  Vaccines to Prevent COVID-19,Other,Guidance,2021-06-04T04:00:00Z,2021,6,2021-06-04T04:00:00Z,,2022-04-25T03:46:23Z,,0,0,0900006484b5633e
FDA-2020-D-1137-0090,FDA,FDA-2020-D-1137,Guidance Documents Related to  Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2021-04-26T04:00:00Z,2021,4,2021-04-26T04:00:00Z,,2024-11-06T23:46:14Z,86 FR 21744,1,0,0900006484ab6bda
FDA-2020-D-1137-0086,FDA,FDA-2020-D-1137,Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing - Guidance for Industry - June 2020,Supporting & Related Material,Background Material,2021-02-22T05:00:00Z,2021,2,,,2021-02-22T16:33:35Z,,0,0,0900006484a46b7c
FDA-2020-D-1137-0087,FDA,FDA-2020-D-1137,TMPRSS2 and TMPRSS4 promote SARS-CoV-2 infection of human small intestinal enterocytes,Supporting & Related Material,Background Material,2021-02-22T05:00:00Z,2021,2,,,2021-02-22T20:34:48Z,,0,0,0900006484a46e11
FDA-2020-D-1137-0085,FDA,FDA-2020-D-1137,Nelfinavir inhibits replication of severe acute respiratory syndrome coronavirus 2 in vitro,Supporting & Related Material,Background Material,2021-02-22T05:00:00Z,2021,2,,,2021-02-22T16:30:39Z,,0,0,0900006484a46b58
FDA-2020-D-1137-0083,FDA,FDA-2020-D-1137,"Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
Guidance for Industry",Other,Guidance,2021-02-09T05:00:00Z,2021,2,2021-02-09T05:00:00Z,2023-05-12T03:59:59Z,2023-05-11T20:53:06Z,,0,0,0900006484a23d3a
FDA-2020-D-1137-0060,FDA,FDA-2020-D-1137,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2020-11-18T05:00:00Z,2020,11,2020-11-18T05:00:00Z,,2021-04-03T01:00:48Z,2020-25399,0,0,0900006484966237
FDA-2020-D-1137-0049,FDA,FDA-2020-D-1137,Reference 15 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:08:24Z,,0,0,0900006484946de1
FDA-2020-D-1137-0053,FDA,FDA-2020-D-1137,Reference 19 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:08:58Z,,0,0,0900006484946de9
FDA-2020-D-1137-0041,FDA,FDA-2020-D-1137,Reference 6 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:07:23Z,,0,0,0900006484946dd9
FDA-2020-D-1137-0038,FDA,FDA-2020-D-1137,Reference 2 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:07:00Z,,0,0,09000064849467af
FDA-2020-D-1137-0043,FDA,FDA-2020-D-1137,Reference 8 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:07:38Z,,0,0,0900006484946ddb
FDA-2020-D-1137-0044,FDA,FDA-2020-D-1137,Reference 9 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:07:45Z,,0,0,0900006484946ddc
FDA-2020-D-1137-0052,FDA,FDA-2020-D-1137,Reference 18 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:08:51Z,,0,0,0900006484946de8
FDA-2020-D-1137-0047,FDA,FDA-2020-D-1137,Reference 13 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:08:09Z,,0,0,0900006484946ddf
FDA-2020-D-1137-0057,FDA,FDA-2020-D-1137,Reference 23 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:09:30Z,,0,0,0900006484946ded
FDA-2020-D-1137-0040,FDA,FDA-2020-D-1137,Reference 4 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:07:16Z,,0,0,0900006484946dd8
FDA-2020-D-1137-0048,FDA,FDA-2020-D-1137,Reference 14 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:08:16Z,,0,0,0900006484946de0
FDA-2020-D-1137-0039,FDA,FDA-2020-D-1137,Reference 3 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:07:07Z,,0,0,09000064849467b0
FDA-2020-D-1137-0050,FDA,FDA-2020-D-1137,Reference 16 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:08:31Z,,0,0,0900006484946de6
FDA-2020-D-1137-0046,FDA,FDA-2020-D-1137,Reference 12 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:08:00Z,,0,0,0900006484946dde
FDA-2020-D-1137-0055,FDA,FDA-2020-D-1137,Reference 21 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:09:15Z,,0,0,0900006484946deb
FDA-2020-D-1137-0037,FDA,FDA-2020-D-1137,Reference 1 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:06:53Z,,0,0,09000064849467ae
FDA-2020-D-1137-0051,FDA,FDA-2020-D-1137,Reference 17 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:08:38Z,,0,0,0900006484946de7
FDA-2020-D-1137-0042,FDA,FDA-2020-D-1137,Reference 7 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:07:29Z,,0,0,0900006484946dda
FDA-2020-D-1137-0056,FDA,FDA-2020-D-1137,Reference 22 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:09:23Z,,0,0,0900006484946dec
FDA-2020-D-1137-0045,FDA,FDA-2020-D-1137,Reference 10 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:07:53Z,,0,0,0900006484946ddd
FDA-2020-D-1137-0054,FDA,FDA-2020-D-1137,Reference 20 re Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Supporting & Related Material,Background Material,2020-11-02T05:00:00Z,2020,11,,,2020-11-02T20:09:05Z,,0,0,0900006484946dea
FDA-2020-D-1137-0036,FDA,FDA-2020-D-1137,Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry,Other,Guidance,2020-11-02T05:00:00Z,2020,11,2020-11-02T05:00:00Z,,2023-10-20T20:52:16Z,,0,0,0900006484946dee
FDA-2020-D-1137-0033,FDA,FDA-2020-D-1137,Ref 7 - Arabi re Investigational COVID-19 Convalescent Plasma; Guidance for Industry,Supporting & Related Material,Background Material,2020-10-30T04:00:00Z,2020,10,,,2020-10-30T16:27:18Z,,0,0,090000648486b9c9
FDA-2020-D-1137-0028,FDA,FDA-2020-D-1137,Ref 4 - Duan re Investigational COVID-19 Convalescent Plasma; Guidance for Industry,Supporting & Related Material,Background Material,2020-10-30T04:00:00Z,2020,10,,,2020-10-30T16:27:15Z,,0,0,090000648486b873
FDA-2020-D-1137-0034,FDA,FDA-2020-D-1137,Ref 6 - Leider re Investigational COVID-19 Convalescent Plasma; Guidance for Industry,Supporting & Related Material,Background Material,2020-10-30T04:00:00Z,2020,10,,,2020-10-30T16:27:19Z,,0,0,090000648486b9c8
FDA-2020-D-1137-0029,FDA,FDA-2020-D-1137,Ref 3 - Chen re Investigational COVID-19 Convalescent Plasma; Guidance for Industry,Supporting & Related Material,Background Material,2020-10-30T04:00:00Z,2020,10,,,2020-10-30T16:27:16Z,,0,0,090000648486b872
FDA-2020-D-1137-0035,FDA,FDA-2020-D-1137,Ref 5 - Cheng re Investigational COVID-19 Convalescent Plasma; Guidance for Industry,Supporting & Related Material,Background Material,2020-10-30T04:00:00Z,2020,10,,,2020-10-30T16:27:19Z,,0,0,090000648486b9c7
FDA-2020-D-1137-0031,FDA,FDA-2020-D-1137,Ref 1 - Roback re Investigational COVID-19 Convalescent Plasma; Guidance for Industry,Supporting & Related Material,Background Material,2020-10-30T04:00:00Z,2020,10,,,2020-10-30T16:27:17Z,,0,0,090000648486b870
FDA-2020-D-1137-0030,FDA,FDA-2020-D-1137,Ref 2 - Shen re Investigational COVID-19 Convalescent Plasma; Guidance for Industry,Supporting & Related Material,Background Material,2020-10-30T04:00:00Z,2020,10,,,2020-10-30T16:27:16Z,,0,0,090000648486b871
FDA-2020-D-1137-0032,FDA,FDA-2020-D-1137,REFERENCES LIST re Investigational COVID-19 Convalescent Plasma; Guidance for Industry,Supporting & Related Material,Background Material,2020-10-30T04:00:00Z,2020,10,,,2020-10-30T16:27:18Z,,0,0,090000648486b86f
FDA-2020-D-1137-0017,FDA,FDA-2020-D-1137,Investigational COVID–19 Convalescent Plasma; Guidance for Industry; Withdrawal of Guidance; Correction,Notice,Correction,2020-10-07T04:00:00Z,2020,10,2020-10-07T04:00:00Z,,2021-02-09T19:31:29Z,2020-22142,0,0,09000064848e55db
FDA-2020-D-1137-0019,FDA,FDA-2020-D-1137,Emergency Use Authorization for Vaccines to Prevent COVID-19 - Guidance for Industry  - October 2020,Other,Guidance,2020-10-06T04:00:00Z,2020,10,2020-10-09T04:00:00Z,,2025-06-15T09:00:19Z,,1,0,09000064848efd71
FDA-2020-D-1137-0018,FDA,FDA-2020-D-1137,Investigational COVID-19 Convalescent Plasma; Guidance for Industry - FINAL,Other,Guidance,2020-09-21T04:00:00Z,2020,9,2020-10-08T04:00:00Z,,2024-11-06T23:39:54Z,,1,0,090000648486b9b9
FDA-2020-D-1137-0011,FDA,FDA-2020-D-1137,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2020-08-03T04:00:00Z,2020,8,2020-08-03T04:00:00Z,,2021-02-09T19:31:14Z,2020-16852,0,0,09000064847ccc08
FDA-2020-D-1137-0008,FDA,FDA-2020-D-1137,"Guidance Documents Related to Coronavirus Disease 2019 (COVID–19);
Availability",Notice,Notice of Availability,2020-05-26T04:00:00Z,2020,5,2020-05-26T04:00:00Z,,2021-02-09T19:30:57Z,2020-11238,0,0,09000064846ac689
FDA-2020-D-1137-0007,FDA,FDA-2020-D-1137,"Guidance Documents Related to Coronavirus Disease 2019 (COVID–19);
Availability",Notice,Notice of Availability,2020-05-12T04:00:00Z,2020,5,2020-05-12T04:00:00Z,,2021-02-09T19:30:39Z,2020-10146,0,0,09000064845cd128
FDA-2020-D-1137-0002,FDA,FDA-2020-D-1137,Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency Guidance for Industry,Other,Guidance,2020-04-03T04:00:00Z,2020,4,2020-04-03T04:00:00Z,,2024-11-06T23:35:19Z,,1,0,090000648448551c
FDA-2020-D-1137-0001,FDA,FDA-2020-D-1137,NOA - Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,Notice,Announcement,2020-03-25T04:00:00Z,2020,3,2020-03-25T04:00:00Z,,2020-09-18T22:29:39Z,2020-06222,0,0,0900006484466342