COVID-19: FDA Clarifies New Guidance, NCI Role
An official from the US agency focused on new coronavirus diagnostic guidance, testing for asymptomatic individuals, and a National Cancer Institute validation project in a recent teleconference.
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The US agency has authorized the first COVID-19 test to use at-home saliva sample collection. Rutgers Clinical Genomics Laboratory landed the emergency use authorization.
A negative COVID-19 antibody or serology test, even when authorized by FDA, is a poor indicator of whether an individual currently has or is completely immune from contracting coronavirus, the agency said on 4 May, issuing an updated guidance to drive the lesson home.
It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one.