FDA to Enhance Oversight of Diagnostic and Other Testing
August 8, 2014 | Strategic Insights for Ambulatory Care
The U.S. Food and Drug Administration (FDA) has taken steps to increase its oversight of certain tests used to diagnose and treat patients. In order to ensure the accuracy and reliability of testing, FDA will issue guidance on companion diagnostic tests used to identify patients who may benefit from or be harmed by treatment with specific drugs. The agency will also publish a risk-based oversight framework for laboratory-developed tests intended to focus its attention on the highest-risk tests.