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INFORMATION FOR

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In this section: Coronavirus Disease 2019 (COVID-19)
 * Coronavirus Disease 2019 (COVID-19)
    * COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other
      Stakeholders
    * COVID-19 Frequently Asked Questions
    * COVID-19 Vaccines
    * Innovation to Respond to COVID-19
    * COVID-19 Educational Resources
    * COVID-19 Communication Toolkits
    * Multilingual COVID-19 Resources
   
   

 1. Home
 2. Emergency Preparedness and Response
 3. Counterterrorism and Emerging Threats
 4. Coronavirus Disease 2019 (COVID-19)
 5. COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other
    Stakeholders

 1. Coronavirus Disease 2019 (COVID-19)


COVID-19-RELATED GUIDANCE DOCUMENTS FOR INDUSTRY, FDA STAFF, AND OTHER
STAKEHOLDERS

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The FDA is committed to providing timely recommendations, regulatory
information, guidance, and technical assistance necessary to support rapid
coronavirus disease 2019 (COVID-19) response efforts. As a result of the
COVID-19 pandemic, a Public Health Emergency (PHE) Declaration was issued by the
Health and Human Services Secretary, on January 31, 2020, and has been
subsequently renewed.  Additional information on the PHE Declaration is
available at Public Health Emergency Declarations.


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 announcing the availability of all COVID-19-related
guidance documents FDA issued during the relevant period. When published in the
Federal Register, the notices are listed below:.


NOTICE OF AVAILABILITY: GUIDANCE DOCUMENTS RELATED TO CORONAVIRUS DISEASE 2019

 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, May 12, 2020)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, May 26, 2020)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, June 26, 2020)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, August 3, 2020)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, September 9, 2020)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, October 16, 2020)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, November 18, 2020)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, January 4, 2021)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, February 19, 2021)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, April 23, 2021)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, May 27, 2021)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, July 23, 2021)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, October 6, 2021)
 * Agency Information Collection Activities; Proposals, Submissions, and
   Approvals: Transition Plan for Medical Devices Issued Emergency Use
   Authorizations During the Coronavirus Disease 2019 Public Health Emergency
   (Federal Register, December 22, 2021)
 * Agency Information Collection Activities; Proposals, Submissions, and
   Approvals: Transition Plan for Medical Devices That Fall Within Enforcement
   Policies Issued During the Coronavirus Disease 2019 Public Health Emergency
   (Federal Register, December 22, 2021)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, January 21, 2022)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, March 4, 2022)
 * Notice of Availability: Guidance Documents Related to Coronavirus Disease
   2019 (COVID-19) (Federal Register, April 22, 2022)


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. As such, guidance
documents where prior public participation is not feasible or appropriate are
implemented immediately, but remain subject to comment. Although FDA immediately
implemented most COVID-19 related guidances, FDA will consider all comments
received on any guidances and revise the guidance documents when appropriate.

--------------------------------------------------------------------------------

Filter by Keywords Showing 1 to 10 of 79 entries
Filter by Product Area Medical DevicesFood & BeveragesDrugsBiologicsAnimal &
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TitleGuidance TypeProduct AreaDate Posted Supplements for Approved Premarket
Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for
Industry and FDA Staff

Biologics
Medical Devices

May 04, 2022 Emergency Use Authorization for Vaccines to Prevent COVID-19
(Updated)  Final Guidance for Industry Biologics March 31, 2022 COVID-19 Public
Health Emergency Policy on COVID-19-Related Sanitation Tunnels Final Guidance
for Industry and Investigators Drugs February 8, 2022 Nonclinical Considerations
for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19
Pandemic Final Guidance for Industry Biologics
Drugs February 4, 2022 Investigational COVID-19 Convalescent Plasma Final
Guidance for Industry Biologics January 7, 2022 Transition Plan for Medical
Devices That Fall Within Enforcement Policies Issued During the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency Draft Guidance for Industry and
Food and Drug Administration Staff Medical Devices December 22, 2021 Transition
Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency Draft Guidance for
Industry and Food and Drug Administration Staff Medical Devices December 22,
2021 Policy for Certain REMS Requirements During the Tocilizumab Shortage
Related to the COVID-19 Public Health Emergency Guidance for Industry and Health
Care Professionals Biologics
Gene Therapy December 10, 2021 Enforcement Policy for Viral Transport Media
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
Final Guidance for Commercial Manufacturers, Clinical Laboratories, and FDA
Staff Medical Devices November 15, 2021 Policy for Coronavirus Disease-2019
Tests During the Public Health Emergency (Revised) Final Guidance for Developers
and Food and Drug Administration Staff Medical Devices November 15, 2021

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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.


   CONTENT CURRENT AS OF:
   
   05/06/2022

 * 

 * Coronavirus Disease 2019 (COVID-19)
    * COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other
      Stakeholders
    * COVID-19 Frequently Asked Questions
    * COVID-19 Vaccines
    * Innovation to Respond to COVID-19
    * COVID-19 Educational Resources
    * COVID-19 Communication Toolkits
    * Multilingual COVID-19 Resources
   
   




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