Why FDA’s issuance of EUAs are not ‘approvals’ and why that matters

RAPS

3 April 2020 - You may have read that some drugs are now “approved” to treat COVID-19, or as the New York Times reported yesterday, that the US FDA “approved” the first serology test for COVID-19, or that the dozens of marketed COVID-19 diagnostics are “approved” by FDA.

But in reality, FDA still has not approved any treatment or test for COVID-19 and has instead issued what are known as emergency use authorisations, or EUAs. 

From an outsider’s perspective, the difference between an approval and an EUA may seem like semantics, but EUAs and full approvals are significantly different.

Read Regulatory Affairs Professional Society article

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Regulation , COVID-19