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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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55 rows where docket_id = "FDA-2020-D-1137" sorted by posted_date descending

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posted_year 4

  • 2020 39
  • 2021 9
  • 2022 4
  • 2023 3

document_type 3

  • Supporting & Related Material 32
  • Notice 12
  • Other 11

agency_id 1

  • FDA 55
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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