It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2
FDA Law Blog
MARCH 16, 2023
The inclusion of a requirement to test twice over three days with at least 48 hours between tests is consistent with study findings from the National Institute of Health published in 2022 ( LINK ); however, it is not clear if this proposed use case is practical for “point-of-care” outside of an in-patient setting.
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