Republicans, Labs Call For Economic Analysis Of FDA's LDT Framework

September 9, 2014 at 6:51 PM
House GOP lawmakers and a major laboratory group want FDA to analyze how its proposed framework to regulate laboratory developed tests (LDTs) would impact industry, and they also question the agency's ability to implement the plan without additional resources such as user fees. The concerns were raised at a House Energy & Commerce Committee hearing Tuesday (Sept. 9) on FDA's framework for regulating LDTs, which first targets “high-risk” tests. The agency sent Congress a controversial notice at the end of...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.