FDA Puts Strengthened Emergency Authority To Use For Diagnostics

The agency’s diagnostic office is putting to the test new authority to grant emergency use authorization for a product before an emergency is officially declared, with an upcoming coronavirus test and a recently authorized flu test.

FDA diagnostic officials say they are making good use of a recently enacted law that allows the agency to grant emergency use authorization to products for public health issues even before they are officially designated emergencies.

The agency has had authority for years to temporarily approve drugs, diagnostics and other tools with less evidence than the...

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