PM360 – Leveraging Emergency Use Authorizations to Bring COVID-19 Products to Market

With the emergence of the COVID-19 crisis, the scientific and medical communities have been tasked with bringing diagnostic and treatment modalities to patients in an expedited but safe manner. To help address this critical need, the Secretary of the U.S. Department of Health and Human Services (HHS) has declared a number of Emergency Use Authorizations (EUAs), which allow the FDA to help strengthen public health protections against the novel coronavirus threat by facilitating the availability and use of necessary medical countermeasures during this global health crisis.

What is an Emergency Use Authorization (EUA)?

EUAs are not unique to the COVID-19 pandemic. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the HHS has declared an emergency, the FDA Commissioner has the authority to allow unapproved medical products or unapproved uses of approved medical products to be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, and nuclear (CBRN) threats when there are no adequate, approved, and available alternatives…

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