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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.
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Workshop_in_brief
·2021
The U.S. Food and Drug Administration (FDA) has responsibility for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. In certain declared emergencies, FDA has the option to authorize use of a new product or a new use of an appr...
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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