Share on twitterShare on linkedinShare on google_plusone_shareShare on emailShare on print Subscribe to Regulatory News Q&A: Lawyer John Conley Counters Lab Industry Arguments against FDA Regulatory Authority over LDTs Jan 15, 2015 | Turna Ray

NEW YORK (GenomeWeb) – Lawyers for the American Clinical Laboratory Association last week issued a white paper laying out their legal arguments against regulation of lab-developed tests (LDTs) by the US Food and Drug Administration.

The 25-page white paper follows FDA's release in October of a draft guidance outlining a nine-year framework for regulating LDTs. In an interview with GenomeWeb this week, lawyers Paul Clement and Laurence Tribe discussed, among other items, how Congress never intended FDA to have statutory authority over lab testing services. more