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QUOTED. 20 April 2020. Stephen Hahn.

Executive Summary

The US FDA is still performing user-fee review activities despite the ongoing coronavirus pandemic – but how long will that be possible? Here’s what FDA Commissioner Stephen Hahn had to say recently.

“With many staff in CDRH working on COVID-19 activities related to pre-emergency use authorizations (pre-EUAs), EUAs, and immediately-in-effect guidance documents, it is possible that we will not be able to sustain our current level of performance indefinitely.” - Stephen Hahn, commissioner, US FDA

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