FDA rushed to authorize COVID tests, IG report says
(CNN) - A government watchdog report found the Food and Drug Administration’s rush to authorize COVID-19 tests early in the pandemic “came at a potential cost to test quality.”
The report from the Office of the Inspector General at the Department of Health and Human Services was published Wednesday online.
In the first five months of the pandemic, the FDA issued more than 100 emergency use authorizations for COVID-19 diagnostic and antibody serology tests.
According to the IG report, the rush resulted in “some problematic tests” being used.
Once those tests were on the market, the FDA had to take further action to address the issue.
The office of the inspector general recommended that the FDA “assess and, as appropriate, revise guidance for test EUA submissions.”
The report noted the FDA “concurred with its recommendations.”
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