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FDA Urged To Moderate Evidence Requirements In LDT Framework

The agency will need to restrain evidence expectations for proving clinical validity in its planned framework for regulating laboratory-developed tests in order to make the framework more feasible, speakers at a Sept. 18 Avalere conference said.

FDA may have to moderate its data expectations for providing clinical validity of laboratory-developed tests if its newly planned framework is going to be feasible to implement, speakers at a Sept. 18 diagnostics policy conference said.

The framework would subject makers of LDTs, which are diagnostic services offered from the same lab in which...

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