
Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Other recent legal actions include a self-disclosure settlement and punishment for alleged improper diagnostic test add-ons
The recent 8-1 decision expands the DOJ’s power to request such cases be thrown out.