This workshop will examine the U.S. Food and Drug Administration’s historic and recent use of the Emergency Use Authorizations (EUAs) for diagnostics, therapeutics, and vaccines. It will also 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.
The workshop will feature the following sessions:
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
How Should the Emergency Use Authorization Authority be Used for Future Pandemics?
The Path Forward: Equities and Enhanced Preparation for the Future