ARTICLE | Politics & Policy

21st Century lawmakers want feedback on LDTs

December 11, 2014 3:44 AM UTC

The House Energy and Commerce Committee issued a (see BioCentury, May 5).

FDA fomally released two draft guidances outlining its plans to regulate LDTs in October (see BioCentury, Aug. 11). In its call for comments, the House committee said the guidance documents "would fundamentally alter the regulatory landscape for LDTs, "including innovative companion diagnostics," and said it was necessary to modernize governmental oversight "of these unique and increasingly important medical products." ...