Heather Pearson

Heather Pearson

Bass, Berry & Sims PLC

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The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more

5/7/2024  /  Clinical Laboratory Testing , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Pharmaceutical Industry , Proposed Rules , Regulatory Oversight , Regulatory Requirements
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