IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed FDA LDT guidance. Among the interesting insights are that FDA officials will not be surprised if some labs file a lawsuit challenging […]
Official Makes Case in Favor of FDA LDT Guidance
Despite criticism from clinical labs, he says FDA will continue to pursue regulation of lab-developed tests
- By Mary Van Doren
- > From the Volume XXII, Number 18 - December 28, 2015 Issue
