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LDTs Around the World

LDTs Around the World

by Michael Schubert, PhD | Jun 4, 2024 | Enforcement-lca, Essential, Lab Industry Advisor, LDTs-lir, Legislation-lca, Top of the News-lir

Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions

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3 Thoughts on the FDA’s Final LDTs Rule

3 Thoughts on the FDA’s Final LDTs Rule

by Rachel Muenz | May 14, 2024 | News

Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs

A Debate—Resolved: Immunohistochemistry Should Be Regulated As An Assay

A Debate—Resolved: Immunohistochemistry Should Be Regulated As An Assay

by G2 Intelligence Staff | Mar 18, 2024 | OLP-Regular, Webinars, webinars free

Join G2 Intelligence for this interactive discussion about whether clinical immunohistochemistry testing should be a stain or an assay, with our experts offering arguments for and against the proposed changes

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