Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions

BY LAURA DIANGELO, MPH

In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). While the agency has been working to implement its rule, which has broad-reaching impacts for diagnostics and drug developers, other moves by the Supreme Court and legislators could impact the agency’s next steps. AgencyIQ provides a status update for regulated industry.

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