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regulatory guidance

The agency recognized that having some companion tests approved for a few but not all cancer drugs with the same molecularly defined indication is not optimal for patient care.

Representatives spoke to serology test accuracy, CLIA categorization of tests, and new sample types, among other issues.

The agency provided an overview of its policies regarding COVID-19 test regulations, as well as additional color and clarification, in a webinar.

Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.

In a guidance, the agency described expanded policies that will enable manufacturers, local labs, and others to quickly deploy coronavirus testing. 

The sponsors of the VALID Act say it's time to modernize outdated diagnostic regulations slowing down test access during a public health crisis.  

SARS-CoV-2 viral material is available for test validation, and the FDA is conducting a rolling review process with an abbreviated submission template.

According to a US Food and Drug Administration webinar yesterday, a lot of IDT test kits has been qualified by CDC and is authorized for purchase.

The proposed Medicines and Medical Devices Bill updates the framework for regulating IVDs following the UK's exit from the EU.

IVD manufacturers are hoping questions related to the UK's pending exit from the EU, as well as the new European IVD Regulation, will soon be resolved.

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