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41 rows where docket_id = "FDA-2020-D-1136" sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;