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FDA’s Final LDT Rule – Stricter Regulatory Requirements In his recently published white paper on Today’s Clinical Lab James Gilmore CEO of The Laboratory Integration Strategic Association (LISA) emphasizes increasing urgency for CAP/COLA laboratories as FDA’s Final Rule on Laboratory-Developed . . .

LISA CEO James Gilmore reveals why the crowdfunding effort for diagnostic assays is a game-changing strategy for managing the new regulatory costs associated with laboratory-developed tests (LDTs). As the FDA’s final rule on Laboratory-Developed Tests (LDTs) reshapes the regulatory landscape . . .