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Report: FDA Greenlit Record Diagnostics, Improved PMA Decision Times Despite COVID-19

Despite industry concerns the US FDA may be significantly falling behind on non-COVID-19 product reviews, analysts at Wells Fargo find that the agency has actually improved in areas such as PMA decision times.

Entrance to FDA headquarters in Maryland

Perhaps unsurprisingly, the US Food and Drug Administration reviewed and authorized a record number of diagnostic tests during the COVID-19 pandemic. But what may be surprising is the agency was able to still maintain its user-fee obligations for the most part – and even improved in some areas – according to an analyst report.

“Although investors have been concerned that FDA review times would increase during COVID, that does not appear to be the...

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