Pilot Geared Toward Sponsors of Certain Oncology Drug Products Used with Certain In Vitro Diagnostic Tests to Identify Patients for Certain Cancer Treatments SILVER SPRING, Md., June 20, 2023 ...
The U.S. FDA reported a pilot program for validation of lab-developed tests (LDTs) used as companion diagnostics, a move that seems an implicit recognition that test kits as CDx products are not the ...
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