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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 approved product - an authority known as Emergency Use Authorization (EUA)- if it has reason to believe that the product may be effective and that its known benefits outweigh its known risks. By contrast, in non-emergency situations, applicants must demonstrate a product's safety and effectiveness through a lengthier, more extensive process.
On October 5-6, 2021, the Committee on Science, Technology, and Law of the National Academies of Sciences, Engineering, and Medicine convened a virtual workshop on the EUA process. At the workshop, presenters and participants examined FDA's recent and historic use of EUAs, discussed lessons learned during the COVID-19 pandemic, and considered how those lessons might inform future efforts. The workshop also highlighted emergency mechanisms used by other health regulators and considered how U.S. and global regulatory partners can strengthen cooperation in responding to global health emergencies. This publication summarizes the presentation and discussion of the workshop.
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