ACLA Signals Litigation If FDA Proceeds With LDT Oversight Plan

If FDA finalizes its draft framework for laboratory developed tests (LDTs), the American Clinical Laboratory Association (ACLA) would consider litigation, the group said as it tapped a former Solicitor General and Harvard professor to represent the group as it resists FDA's controversial move to regulate LDTs. This occurs as stakeholders on opposing sides of the issue Tuesday (Nov. 18) ramped up lobbying: ACLA and almost 50 other organizations asked FDA to rescind its proposed LDT guidance, while clinical oncologists and...