OIG: FDA’s EUA Approach Allowed Bad Tests To Reach Market

A review by a government watchdog found the FDA’s review process for COVID-19 diagnostics was plagued by issues including allowing low-quality tests to slip through, high reviewer workloads, and manufacturer frustration.

Test tube with blood sample for COVID-19 test, novel coronavirus 2019 found in Wuhan, China

More from Regulation

More from Policy & Regulation