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Most COVID-related EUAs backed by low-quality data, review finds
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Most US Food and Drug Administration (FDA)-issued emergency use authorizations (EUAs) for COVID-19–related medical products were not supported by high-quality data, and the FDA revoked authorizations for 17 products because of effectiveness or safety problems, according to a research letter yesterday in JAMA Internal Medicine.The authors say that relying on suboptimal supporting data is understandable at the beginning of a pandemic, but standards should be raised later on.EUAs allow the FDA to expedite medical products to market under public health emergency declarations from the US Department of Health and Human Services.
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