‘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.
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US FDA officials speaking during a 24 June webinar emphasized the role manufacturers can play in ensuring COVID-19 diagnostics make it through the agency’s emergency use authorization (EUA) process swiftly.
A top FDA official said the agency has more than doubled its virology review staff to handle the cascade of EUA applications. He said the agency is prioritizing certain COVID-19 diagnostics during a recent webinar.
The FDA’s initial lack of oversight of the tests shows why it is important for the agency to continue its public health responsibility in ensuring safe and effective products get to market, a panel of experts told lawmakers.