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The FDA’s Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: A Workshop

October 5, 2021 - October 6, 2021

Virtual Event Virtual Event

The National Academies’ will host a workshop to examine the U.S. Food and Drug Administration’s historic and recent use of the Emergency Use Authorizations (EUAs) for diagnostics, therapeutics, and vaccines.

The event will provide an overview of the current regulatory framework for EUAs and discuss whether any possible revisions would help to ensure that EUAs are based upon the best and most reliable scientific evidence or enhance public confidence and trust in the EUA process and products.

The workshop will also examine EUAs and similar mechanisms used by other entities within the global health regulatory system, lessons that U.S. and global regulatory and public health partners can learn from one another, and ways to enhance international cooperation between the FDA and its global partners.

Highlighted sessions include:

  • An Overview of Emergency Use Authorizations and Similar Authorities
  • Use of the Emergency Use Authorization During the COVID-19 Pandemic
  • Communication and Transparency for Emergency Use Authorizations Used During the COVID-19 Pandemic
  • An Evaluation of the Process for Authorizing Emergency Use Authorizations and Transitioning to Full Approval
  • International Cooperation
  • How Should the Emergency Use Authorization Authority be Used for Future Pandemics?
  • The Path Forward: Equities and Enhanced Preparation for the Future

A brief proceedings of the workshop will be published. Please visit NASEM’s FDA’s Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: A Workshop website for more information.

 

 

Organizer

National Academies of Sciences, Engineering, and Medicine
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