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ACLA Rejects FDA As A ‘Clinical Validity’ Judge, While AdvaMedDx Seeks Tweaks To VALID Act

Executive Summary

Clinical labs are troubled by the idea of granting US FDA vast discretion to determine if laboratory-developed tests (LDTs) are analytically and clinically valid, a key feature of the draft US VALID Act, while in vitro diagnostic kit manufacturers want some clarifications and more flexibility written into the proposal for diagnostic regulatory reforms.

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