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‘Email Me’: FDA Director Says He’ll Cut Through Red Tape To Ensure EUAs Are Assigned Liaison

As the number of emergency use applications (EUAs) for COVID-19 tests have mushroomed, the director of the US FDA’s in vitro diagnostics division says he’s directed his office to ensure all sponsors are assigned an agency liaison within two weeks of receiving a completed application. And if an officer isn’t assigned, Timothy Stenzel told sponsors to personally reach out to him so he can intervene on their behalf.

The top dog at the US Food and Drug Administration responsible for review of in vitro diagnostics told sponsors he is taking personal responsibility for ensuring their COVID-19 emergency use authorization (EUA) applications do not get stalled in a bureaucratic quagmire because they haven’t been assigned an agency liaison.

Timothy Stenzel also told companies to email him if they face such a challenge.

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