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Administrative Procedure Act Laboratory Developed Tests Regulatory Requirements

Baker Donelson

Federal Court Vacates LDT Final Rule

Baker Donelson on

The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 3 – Legal Challenges

This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance of the U.S. Food & Drug Administration...more

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