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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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