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Home » FDA’s Stenzel says staff surge working as evidenced by 65 serology decisions in two weeks
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FDA’s Stenzel says staff surge working as evidenced by 65 serology decisions in two weeks

Dec. 9, 2020
By Mark McCarty
The latest U.S. FDA town hall for diagnostics included the usual technical questions about test validation, but there are some frustrations among test developers regarding turn-around times for emergency use authorizations (EUAs). Nonetheless, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health (OIR) at the FDA, said the surge in staff assigned to review EUA filings has worked to some benefit, claiming that the agency has rendered a decision in connection with 65 applications in the two weeks leading up to the Dec. 9 town hall.
BioWorld MedTech Regulatory Coronavirus U.S. FDA

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