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41 rows where docket_id = "FDA-2020-D-1136" sorted by posted_date descending

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posted_year 4

  • 2020 22
  • 2021 12
  • 2023 5
  • 2022 2

document_type 2

  • Other 26
  • Notice 15

agency_id 1

  • FDA 41
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1136-0085 FDA None FDA-2020-D-1136 Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization Other Guidance 2023-12-22T05:00:00Z 2023 12 2023-12-22T05:00:00Z   2024-11-12T06:25:32Z   1 0 090000648634e5c5
FDA-2020-D-1136-0084 FDA None FDA-2020-D-1136 Development of Monoclonal Antibody Products Targeting SARS–CoV–2 for Emergency Use Authorization; Guidance for Industry; Availability Notice Notice of Availability 2023-12-21T05:00:00Z 2023 12     2023-12-21T16:06:18Z 2023-28092 0 0 090000648634e184
FDA-2020-D-1136-0083 FDA None FDA-2020-D-1136 Food and Drug Administration; Center of Drug Evaluation and Research Guidance Documents Related to Coronavirus Disease 2019, Expiration Notice Withdrawal 2023-10-19T04:00:00Z 2023 10 2023-10-19T04:00:00Z   2023-10-19T13:20:17Z 2023-23071 0 0 090000648610bf60
FDA-2020-D-1136-0082 FDA None FDA-2020-D-1136 Guidance Documents Related to Coronavirus Disease 2019 (COVID–19) Notice General Notice 2023-03-13T04:00:00Z 2023 3 2023-03-13T04:00:00Z   2023-03-13T14:28:59Z 2023-05094 0 0 090000648579bdb9
FDA-2020-D-1136-0081 FDA None FDA-2020-D-1136 Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID–19 Public Health Emergency; Withdrawal of Guidance Notice Withdrawal 2023-02-10T05:00:00Z 2023 2 2023-02-10T05:00:00Z   2023-02-10T15:41:04Z 2023-02809 0 0 0900006485653eb7
FDA-2020-D-1136-0079 FDA None FDA-2020-D-1136 Guidance Documents Related to Coronavirus Disease 2019; Availability Notice Notice of Availability 2022-03-04T05:00:00Z 2022 3 2022-03-04T05:00:00Z   2023-05-12T20:07:30Z 2022-04637 0 0 0900006484fb7be1
FDA-2020-D-1136-0077 FDA None FDA-2020-D-1136 COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation Tunnels; Guidance for Industry and Investigators Other Guidance 2022-02-08T05:00:00Z 2022 2 2022-02-08T05:00:00Z 2023-05-12T03:59:59Z 2023-05-08T17:01:37Z   0 0 0900006484f5e283
FDA-2020-D-1136-0075 FDA None FDA-2020-D-1136 Guidance Documents Related to Coronavirus Disease 2019; Availability Notice Notice of Availability 2021-10-06T04:00:00Z 2021 10 2021-10-06T04:00:00Z   2023-05-12T20:07:03Z 2021-21798 0 0 0900006484dbc502
FDA-2020-D-1136-0074 FDA None FDA-2020-D-1136 Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers; Guidance for Industry Other Guidance 2021-09-08T04:00:00Z 2021 9 2021-09-08T04:00:00Z 2023-05-12T03:59:59Z 2023-05-08T18:53:09Z   0 0 0900006484d5f1ce
FDA-2020-D-1136-0073 FDA None FDA-2020-D-1136 Guidance Documents Related to Coronavirus Disease 2019; Availability Notice Notice of Availability 2021-07-23T04:00:00Z 2021 7 2021-07-23T04:00:00Z   2023-05-12T20:06:35Z 2021-15649 0 0 0900006484c097c2
FDA-2020-D-1136-0066 FDA None FDA-2020-D-1136 Guidance: Documents Related to Coronavirus Disease 2019; Availability Notice Notice of Availability 2021-05-27T04:00:00Z 2021 5 2021-05-27T04:00:00Z   2023-05-12T20:06:17Z 2021-11217 0 0 0900006484b3ca2f
FDA-2020-D-1136-0062 FDA None FDA-2020-D-1136 Guidance Documents Related to Coronavirus Disease 2019; Availability Notice Notice of Availability 2021-04-26T04:00:00Z 2021 4 2021-04-26T04:00:00Z   2024-11-06T23:46:13Z 2021-08474 1 0 0900006484ab6bbf
FDA-2020-D-1136-0057 FDA None FDA-2020-D-1136 Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency; Guidance for Industry Other Guidance 2021-04-14T04:00:00Z 2021 4 2021-04-14T04:00:00Z   2024-11-06T23:47:11Z   1 0 0900006484aa70cf
FDA-2020-D-1136-0056 FDA None FDA-2020-D-1136 Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers - Guidance for Industry - April 2021 U.S. Department of Health and Human Services Food and Drug Administration Center for Other Guidance 2021-04-07T04:00:00Z 2021 4 2021-04-07T04:00:00Z 2023-05-12T03:59:59Z 2023-05-08T18:53:55Z   0 0 0900006484a9f1b6
FDA-2020-D-1136-0051 FDA None FDA-2020-D-1136 COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry March 2021 Other Guidance 2021-03-05T05:00:00Z 2021 3 2021-03-05T05:00:00Z 2021-03-05T04:59:59Z 2024-11-12T23:30:07Z   1 0 0900006484a60779
FDA-2020-D-1136-0050 FDA None FDA-2020-D-1136 Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency - Guidance for Industry - February 2021 Other Guidance 2021-02-22T05:00:00Z 2021 2 2021-02-22T05:00:00Z   2024-11-12T23:30:16Z   1 0 0900006484a459a4
FDA-2020-D-1136-0049 FDA None FDA-2020-D-1136 Guidance Documents Related to Coronavirus Disease 2019; Availability Notice Notice of Availability 2021-02-19T05:00:00Z 2021 2 2021-02-19T05:00:00Z   2024-11-12T23:27:55Z 2021-03421 1 0 0900006484a42ed9
FDA-2020-D-1136-0047 FDA None FDA-2020-D-1136 COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity; Guidance for Industry Other Guidance 2021-01-22T05:00:00Z 2021 1 2021-01-22T05:00:00Z   2024-11-06T23:44:17Z   1 0 09000064849fccda
FDA-2020-D-1136-0046 FDA None FDA-2020-D-1136 Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency Guidance for Industry Other Guidance 2021-01-19T05:00:00Z 2021 1 2021-01-19T05:00:00Z 2023-05-12T03:59:59Z 2023-05-08T18:56:13Z   0 0 09000064849f89c5
FDA-2020-D-1136-0044 FDA None FDA-2020-D-1136 Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry Other Guidance 2020-12-23T05:00:00Z 2020 12 2020-12-23T05:00:00Z 2023-05-12T03:59:59Z 2023-05-08T19:02:22Z   0 0 09000064849bcedf
FDA-2020-D-1136-0040 FDA None FDA-2020-D-1136 Guidance Documents Related to Coronavirus Disease 2019 (COVID–19); Availability Notice Notice of Availability 2020-10-16T04:00:00Z 2020 10 2020-10-16T04:00:00Z   2021-03-05T14:37:40Z 2020-22968 0 0 0900006484912a7f
FDA-2020-D-1136-0064 FDA None FDA-2020-D-1136 Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency Guidance for Industry - September 2020 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Other Guidance 2020-09-10T04:00:00Z 2020 9 2021-04-28T04:00:00Z 2023-05-12T03:59:59Z 2023-05-08T19:44:20Z   0 0 0900006484abaf0f
FDA-2020-D-1136-0035 FDA None FDA-2020-D-1136 Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry Other Guidance 2020-08-19T04:00:00Z 2020 8 2020-08-19T04:00:00Z 2023-11-08T04:59:59Z 2023-05-24T20:08:59Z   0 0 0900006484811bad
FDA-2020-D-1136-0033 FDA None FDA-2020-D-1136 Guidance Documents Related to Coronavirus Disease 2019; Availability Notice Notice of Availability 2020-08-03T04:00:00Z 2020 8 2020-08-03T04:00:00Z   2021-03-05T14:37:26Z 2020-16852 0 0 09000064847ccc07
FDA-2020-D-1136-0024 FDA None FDA-2020-D-1136 Guidance Documents Related to Coronavirus Disease 2019 (COVID–19); Availability Notice Notice of Availability 2020-06-26T04:00:00Z 2020 6 2020-06-26T04:00:00Z   2021-03-05T14:37:11Z 2020-13829 0 0 090000648470facc
FDA-2020-D-1136-0021 FDA None FDA-2020-D-1136 Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing - Guidance for Industry Other Guidance 2020-06-19T04:00:00Z 2020 6 2020-06-19T04:00:00Z 2023-05-12T03:59:59Z 2023-05-08T19:50:01Z   0 0 09000064846fac55
FDA-2020-D-1136-0020 FDA None FDA-2020-D-1136 Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency - Guidance for Industry Other Guidance 2020-06-16T04:00:00Z 2020 6 2020-06-16T04:00:00Z 2023-05-12T03:59:59Z 2023-05-09T19:04:53Z   0 0 09000064846f4ae5
FDA-2020-D-1136-0019 FDA None FDA-2020-D-1136 Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency - Guidance for Industry Other Guidance 2020-06-08T04:00:00Z 2020 6 2020-06-08T04:00:00Z 2023-05-12T03:59:59Z 2023-05-09T19:19:18Z   0 0 09000064846d5e86
FDA-2020-D-1136-0015 FDA None FDA-2020-D-1136 Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications - Questions and Answers Guidance for Industry Other Guidance 2020-05-26T04:00:00Z 2020 5 2020-05-27T04:00:00Z 2023-05-12T03:59:59Z 2023-05-09T19:07:05Z   0 0 09000064846b4184
FDA-2020-D-1136-0014 FDA None FDA-2020-D-1136 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   2021-03-05T14:36:27Z 2020-11238 0 0 09000064846ac913
FDA-2020-D-1136-0013 FDA None FDA-2020-D-1136 Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency - List of Drugs Used for Hospitalized Patients with COVID-19 Other Background Material 2020-05-22T04:00:00Z 2020 5     2023-05-12T14:00:04Z   0 0 090000648467120c
FDA-2020-D-1136-0012 FDA None FDA-2020-D-1136 COVID-19 Public Health Emergency_ General Considerations for Pre-IND_Meeting Requests for COVID-19 Related Drugs and Biological Pr-2 Other Guidance 2020-05-13T04:00:00Z 2020 5 2020-05-13T04:00:00Z 2023-05-12T03:59:59Z 2023-05-09T19:20:08Z   0 0 09000064845e8851
FDA-2020-D-1136-0011 FDA None FDA-2020-D-1136 Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency - Guidance for Industry Other Guidance 2020-05-08T04:00:00Z 2020 5 2020-05-08T04:00:00Z 2023-05-12T03:59:59Z 2023-05-09T19:17:11Z   0 0 0900006484591e7a
FDA-2020-D-1136-0010 FDA None FDA-2020-D-1136 Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency - Guidance for Industry Other Guidance 2020-05-08T04:00:00Z 2020 5 2020-05-08T04:00:00Z 2023-05-12T03:59:59Z 2024-11-12T23:19:39Z   1 0 0900006484591e78
FDA-2020-D-1136-0009 FDA None FDA-2020-D-1136 Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry Other Guidance 2020-04-30T04:00:00Z 2020 4 2020-04-30T04:00:00Z 2023-05-12T03:59:59Z 2023-05-09T19:20:27Z   0 0 090000648452228f
FDA-2020-D-1136-0007 FDA None FDA-2020-D-1136 Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency Guidance for Industry Other Guidance 2020-04-22T04:00:00Z 2020 4 2020-04-22T04:00:00Z   2024-11-06T23:33:49Z   1 0 09000064844c296a
FDA-2020-D-1136-0006 FDA None FDA-2020-D-1136 Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry Other Guidance 2020-04-20T04:00:00Z 2020 4 2020-04-20T04:00:00Z 2023-05-12T03:59:59Z 2023-05-09T19:16:50Z   0 0 09000064844b9a04
FDA-2020-D-1136-0004 FDA None FDA-2020-D-1136 Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry Other Guidance 2020-04-16T04:00:00Z 2020 4 2020-04-16T04:00:00Z 2023-05-12T03:59:59Z 2023-05-09T19:08:50Z   0 0 09000064844abbb7
FDA-2020-D-1136-0003 FDA None FDA-2020-D-1136 Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Other Guidance 2020-04-10T04:00:00Z 2020 4 2020-04-10T04:00:00Z 2023-05-12T03:59:59Z 2023-05-09T19:18:35Z   0 0 0900006484499af1
FDA-2020-D-1136-0002 FDA None FDA-2020-D-1136 Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry Other Guidance 2020-04-09T04:00:00Z 2020 4 2020-04-09T04:00:00Z 2023-11-08T04:59:59Z 2023-05-24T20:07:17Z   0 0 090000648449747d
FDA-2020-D-1136-0001 FDA None FDA-2020-D-1136 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   2021-03-05T14:35:54Z 2020-06222 0 0 090000648446b620

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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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