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FDA Files Closing Brief Defending LDT Regulations

The Food and Drug Administration (FDA) filed its closing brief on December 23 in the federal court case over the regulation of laboratory-developed tests (LDTs). Read the FDA brief.

Previously, the CAP filed an amicus brief urging the court to vacate the FDA regulation for several reasons, including the ultimate impact on patient access to these critically important diagnostic tests and the agency failing to adequately justify the rule’s unsustainable costs that will hinder the development of LDTs.

A final decision is expected in 2025. The CAP will continue to update members on the status.

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