Emergency use authorizations (EUAs)

EMERGENCY USE AUTHORIZATIONS (EUAs)

Emergency use authorizations (EUAs) are one of several tools USFDA is using to make important medical products available quickly on a public health emergency.

 Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved and available alternatives.

EUA process is different than full approval procedure, because in some emergency situation, agency cannot wait for all the evidence need for new drug approval. Instead the FDA evaluates the options very quickly using the evidence that is available and carefully balances any known or potential risks these unproven products with any known or potential benefits to the public of making them available during the emergency.

Abbreviations

CBRN - 'CBRN' is the abbreviation commonly used to describe the malicious use of Chemical, Biological, Radiological and Nuclear materials or weapons with the intentions to cause significant harm or disruption.