New Covid Tests Should Fulfill Unmet Need for Emergency Review

The FDA will focus emergency authorization reviews of new Covid-19 tests on those likely to have a substantial public health benefit or that fulfill an unmet need, the agency announced Tuesday.

The Food and Drug Administration said in revised guidance that “these priorities are appropriate to address the public health needs at the current stage of the public health emergency.” The agency added that the number of new emergency authorization requests that meet these standards for review are likely limited, and is encouraging test developers to otherwise submit Covid-19 tests through traditional premarket review pathways.

“Testing remains one of the ...