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- Closing Briefs Filed in Lawsuits Against FDA LDT Oversight
Plaintiffs filed closing legal briefs late on November 25 in the lawsuit seeking to overturn the Food and Drug Administration regulation for laboratory-developed tests (LDTs). The American Clinical Laboratory Association (ACLA) and Association for Molecular Pathology (AMP) again asked the federal courts to vacate the regulation set to take effect May 6, 2025.
The CAP has filed its own amicus brief urging the court to stop the FDA LDT rule from being implemented. Read the CAP's amicus brief to the court cases ACLA et al. v. FDA, and AMP et al. v. FDA, US District Court Eastern District of Texas. The FDA is scheduled to file its closing brief by December 23.