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BioWorld - Wednesday, July 7, 2021
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Home » Stenzel mum on LDT question, but says FDA ‘overwhelmed’ with EUA filings
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Stenzel mum on LDT question, but says FDA ‘overwhelmed’ with EUA filings

Aug. 26, 2020
By Mark McCarty
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A number of controversies have swirled around the U.S. FDA’s handling of the COVID-19 pandemic, including the question of the emergency use authorization (EUA) program for testing. The FDA’s Tim Stenzel said on an Aug. 26 testing town hall that he would not answer questions about the rescission order for FDA regulation of lab-developed tests (LDTs), but also said, “we are simply overwhelmed” with EUA filings for testing.
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