FDA pushes forward with plans to regulate laboratory-developed tests in a move that will impact many clinical laboratory companies and pathology groups
from DARK Daily
From Sept. 9:
After sitting in a state of suspended animation for several years, the Food and Drug Administration's plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of laboratory-developed tests.
7701 Las Colinas Blvd., Ste. 800, Irving, TX 75063