Controversial Final FDA LDT Rule Cleared By White House

The White House’s Office of Information and Regulatory Affairs (OIRA) has signed off on FDA’s final rule for regulation of laboratory-developed tests (LDTs), indicating that the controversial, much-anticipated rule could be available at any time. It is likely to draw legal action from industry and continued backlash from lawmakers. The FDA has moved quickly throughout the LDT rulemaking process, likely looking to avoid the “midnight rule” at the end of presidential terms that would make it earlier for Congress to...