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Emergency Use Authorizations

Regulatory Consulting

Emergency Use Authorizations (EUA) are a mechanism that allows the U.S. FDA to facilitate the availability of medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) threats, including emerging infectious diseases such as COVID-19 and pandemic influenza, during public health emergencies. Products that receive emergency health authorizations may be legally marketed and sold in the U.S. for the duration of the emergency or until authorization is revoked by FDA.   

Listen to the full episode on Veristat’s Advancing Revolutionary Therapies (ART) Podcast to learn more about the four primary criteria for an Emergency Use Authorization, navigating the U.S. regulatory environment, and the many nuances key to the success of an Emergency Use Authorization application.

Learning Points

  • Qualifications for the Emergency Use Authorization program
  • How to successfully apply for an Emergency Use Authorization
  • Data requirements for Emergency Use Authorizations
  • Converting Emergency Use Authorizations to full approvals

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