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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

9 rows where docket_id = "FDA-2020-D-1137" and posted_year = 2021 sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 3

  • Other 4
  • Supporting & Related Material 3
  • Notice 2

posted_year 1

  • 2021 · 9 ✖

agency_id 1

  • FDA 9
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1137-0110 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

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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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