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The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: A Workshop

Completed

Enacted in 2004, the EUA authority allows FDA to sanction on an expedited basis the sale of unapproved medical products for use in public health emergencies. The EUA has become critically important during the COVID-19 pandemic. Nevertheless, the criteria for issuing an EUA are not well-defined in the statute or in FDA regulations. This workshop examined the FDA's historic and recent use of the EUA. We explored possible additional regulatory standards or guidance that could help ensure that EUAs are based on the best scientific evidence and build public confidence the EUA process and products.

Description

The National Academies of Sciences, Engineering, and Medicine will convene a Planning Committee to organize a workshop to examine FDA’s use of the Emergency Use Authorization (EUA). Enacted in 2004, the EUA authority allows FDA to sanction on an expedited basis the sale of unapproved medical products, including diagnostic tests, therapeutics and vaccines, for use in public health emergencies. A valuable tool for addressing public health emergencies, the EUA has become critically important during the COVID-19 pandemic. Nevertheless, the criteria for issuing an EUA are not well-defined in the statute or in FDA regulations. The workshop will examine FDA's historic and recent use of the EUA for diagnostics, therapeutics, and vaccines. It will also provide an overview of the current regulatory framework for EUAs and discuss possible additional regulatory standards or guidance that could help ensure that EUAs are based on the best and most reliable scientific evidence and build public confidence and trust in the EUA process and products. A brief proceedings of the workshop will be published.

Contributors

Committee

Chair

Member

Member

Member

Member

Member

Member

Member

Anita Eisenstadt

Staff Officer

Sponsors

Private: Non Profit

Rockefeller-Foundation

The Gates Foundation

Staff

Anita Eisenstadt

Lead

Dominic LoBuglio

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