Some COVID-19 Molecular Diagnostics Can Skip Forward To Market For Pooled Screening
The US FDA says as long as the EUA-authorized tests provide a notification with validation data and procedural information, they can be used for pooled serial screening before additional review.
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The agency published a supplemental template for molecular and antigen COVID-19 EUA sponsors whose product can be used for serial testing, and a fact sheet that screening program organizers can use to pick the right test.
US regulators gave the thumbs-up to the first COVID-19 test that pools patient samples to determine if any one of the individuals in the pool may be infected. Despite concerns such tests may be diluted and make it harder to detect the SARS-CoV-2 virus, the FDA says validation data shows it works.
In this week’s podcast, senior reporter Ferdous Al-Faruque gives an early look at how user fee negotiations between the US FDA and industry groups for MDUFA V are unfolding. As in the past, the parties are at odds over how much industry should pay, and what the FDA is using the money for.