FDA Looks to Clamp Down on Laboratory-Developed Tests and Put an End to ‘Wild West of Medicine’: Might CLIA Problems at Theranos Support FDA’s Position?

The Wall Street Journal examines the FDA’s position on LDTs and looks at the pros and cons of LDT regulation by the federal agency National news coverage over the deficiencies uncovered by Clinical Laboratory Improvement Amendments (CLIA) inspections of the clinical laboratory operated by Theranos in Newark, Calif., may have an interesting consequence that affects all […]
Source: Dark Daily - Category: Laboratory Medicine Authors: Tags: Compliance, Legal, and Malpractice Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Management & Operations Alberto Gutier Source Type: news