Process for COVID-19 Related Guidances
In the Federal Register of March 25, 2020, FDA published a Notice announcing the process for making COVID-19 related guidance documents available to the public. The process is in accordance with FDA’s established good guidance practices regulations and will enable FDA to more rapidly disseminate and implement agency recommendations and policies related to COVID-19.
As part of this process, FDA intends to periodically publish a consolidated Notice of Availability (NOA) announcing the availability of all COVID-19-related guidance documents FDA issued during the relevant period. Interested parties can access the NOAs when published in the Federal Register by clicking on the appropriate link contained in the table below listing COVID-19-related guidance documents.
Implementation of COVID-19 Related Guidance Documents
In accordance with FDA’s good guidance practices, FDA will not seek public comment prior to implementing a guidance document if the agency determines that prior public participation is not feasible or appropriate. Guidance documents where prior public participation is not feasible or appropriate are implemented immediately, but remain subject to comment. Although FDA anticipates that it will immediately implement COVID-19 related guidances, FDA will consider all comments received on any guidances and revise the guidance documents when appropriate.
Title |
Type |
Date Posted |
---|
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final Guidance for Industry |
April 14, 2021 |
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19) |
Final Guidance for Industry |
January 19, 2021 |
Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
September 10, 2020 |
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing |
Final Guidance for Industry |
June 19, 2020 |
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry |
Final Guidance for Industry |
June 16, 2020 |
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
March 17, 2020
Updated June 4, 2020 |
Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic |
Final Guidance for Industry |
May 12, 2020 |
CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency |
Final Guidance for Industry |
May 7, 2020 |
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
April 22, 2020 |
CVM GFI #270 - Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency |
Final Guidance for Industry |
April 3, 2020 |
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
March 30, 2020 |
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
March 29, 2020 |
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry |
Final Guidance for Industry |
March 27, 2020 |
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) |
Final Guidance for Industry |
March 24, 2020
Updated March 27, 2020 |
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
March 22, 2020 |
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) |
Final Guidance for Industry |
March 19, 2020
Updated March 27, 2020 |
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency |
Immediately in Effect Guidance for Industry |
March 14, 2020
Updated March 27, 2020 |
About FDA Guidances
Guidance documents represent the agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. For information on a specific guidance document, please contact the originating office.