Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument
FDA Law Blog: Biosimilars
FEBRUARY 20, 2025
Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.
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