CEO SUMMARY: Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern District of Texas, which will continue to oversee the now-unified case as it moves forward. Both plaintiffs […]
Two Different LDT Lawsuits Combined in Federal Court
Lab industry plaintiffs in both lawsuits agree to combine their legal actions against HHS, FDA
- By Robert Michel
- > From the Volume XXXI, No. 16 - November 25, 2024 Issue
- Tags: acla, ADLM, American Association of Bioanalysts, American Clinical Laboratory Association, american society for clinical pathology, American Society for Microbiology, amicus curiae, AMP, Anthony Killeen MD PhD, Association for Diagnostics and Laboratory Medicine, association for molecular pathology, Centers for Medicare and Medicaid Services, CMS, Department of Health and Human Services, FDA, Food and Drug Administration, Food Drug and Cosmetic Act, HealthTrackRx, HHS, Infectious Disease Society of America, Jane Pine Wood JD, lab risk & compliance, laboratory-developed test, ldt, McDonald Hopkins, Michael Laposta MD PhD, Public Health Service Act, United States District Court Eastern District of Texas Sherman Division, University of Texas-Galveston, US District Court for the Southern District of Texas Galveston Division
