The U.S. Food and Drug Administration recently announced that it will no longer review emergency use authorization requests for COVID-19 laboratory developed tests.
In a Law360 article, life sciences regulatory & compliance partner and chair Greg Levine, counsel Beth Weinman and associate Joshua Oyster (all of Washington, D.C.) examine questions raised by the FDA’s new lab test policy.
The authors note that the FDA announcement may create a disincentive for laboratories to continue to develop COVID-19 diagnostics while that policy remains in effect.
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