New Standard Looks At Nanotechnology Biocompatability
The standard helps developers determine whether their products might exude harmful amounts of nitric oxide.
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The US FDA has approved additional indications for Thermo Fisher Scientific’s Oncomine Dx Target, allowing the companion diagnostic to be used to detect more varieties of lung and thyroid cancer.
Committee leaders in the US Congress have agreed on a stripped-down path to user fee reauthorization, which will not include FDA oversight of diagnostic tests.
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.