FDA to Allow Private Companies to Market Coronavirus Test Kits Without Prior Approval - News Summed Up

FDA to Allow Private Companies to Market Coronavirus Test Kits Without Prior Approval


WASHINGTON—The Food and Drug Administration said late Monday that it will allow private companies to begin marketing coronavirus test kits directly to the public, in a new initiative to ease a chronic shortage of test kits. The FDA said it will review the accuracy of test data submitted by the manufacturers retroactively—a decision that FDA Commissioner Stephen Hahn acknowledged had risks, but was warranted by the severity of the pandemic.


Source: Wall Street Journal March 17, 2020 01:06 UTC



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