Q&A: FDA’s LDT Inaction Catches Veteran Attorney Off-Guard

Industry experts expected the US FDA to swiftly reverse a Trump-administration policy blocking oversight of lab-developed tests. Its inaction has one former agency attorney wondering why.

Interview

Medtech industry experts had predicted the US Food and Drug Administration would reverse the Trump administration’s policy preventing it from regulating

laboratory developed tests (LDT). But eight months after a new administration took the help the policy is still in place -- leaving experts like Sidley Austin’s Coleen Klasmeier scratching their...

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