The push-and-pull between the US Department of Health and Human Services and the Food and Drug Administration over laboratory developed tests took a surprising turn today when the agency declared that it will no longer grant emergency use authorizations (EUAs) for LDTs.
That means unapproved COVID-19 tests that come to market without an EUA won’t be covered under the Public Readiness and Emergency Preparedness Act – or PREP Act – which...
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