CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.” ACLA and HealthTrackRx are challenging the FDA’s “genie” in federal court, with the goal of […]
ACLA Files Court Challenge to FDA’s Final LDT Rule
HHS and FDA named as defendants: ACLA and HealthTrackRx are plaintiffs; case filed in Texas
- By Robert Michel
- > From the Volume XXXI, No. 8 - June 10, 2024 Issue
- Tags: acla, American Clinical Laboratory Association, arup laboratories, Ashley Parrish JD, Bruce Quinn MD PhD, Department of Health and Human Services, FDA, FDCA, Federal Register, Food and Drug Administration, Food Drug and Cosmetic Act, HealthTrackRx, HHS, Jay Reddy PhD, Jonathan Genzen MD PhD, lab intelligence, LabCorp, laboratory-developed test, ldt, Marcia Eisenberg PhD, Mayo Clinic, Mayo Clinic Laboratories, Mayo Collaborative Services, Quest Diagnostics, United States District Court Eastern District of Texas Sherman Division, William Morice II MD PhD, www.discoveriesinhealthpolicy.com, Yuri A. Fesko MD
