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Home » FDA will need applications, more data for EUA template for neutralizing antibody tests
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FDA will need applications, more data for EUA template for neutralizing antibody tests

July 16, 2020
By Mark McCarty
The next phase of testing for the COVID-19 pandemic will hopefully include the roll-out of tests for neutralizing antibodies for the SARS-CoV-2 virus, but there are some roadblocks. The FDA’s Tim Stenzel said the agency has a limited amount of information to offer regarding emergency use authorizations for these tests, a predicament that might not resolve until several applicants are in and the agency can see some information that will aid in development of performance and validation standards.
BioWorld MedTech Regulatory Coronavirus Diagnostics U.S. FDA

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