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

 
• By Elizabeth Orr

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

A new report from the US Department of Health and Human Services Office of the Inspector General (OIG) highlights challenges faced by the US Food and Drug Administration and industry alike during the country’s initial struggles with the COVID-19 pandemic.

The report assesses how the FDA used its Emergency Use Authorization (EUA) authority to assess the first COVID-19 tests between...

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More from Regulation

More from Policy & Regulation

House Bill Calls For ‘Non-Flushable’ Label On Personal Wipes

 
• By Eileen Francis

The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.

Medicare Tricuspid Regurgitation Coverage Decision Big Win For Abbott

 
• By Brian Bossetta

Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.

Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.