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55 rows where docket_id = "FDA-2020-D-1137" sorted by posted_date descending
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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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;