U.S. Food and Drug Administration (FDA)
FDA Launches Pilot Program to Guide Accuracy of Diagnostic Lab Tests for Cancer Biomarkers
A new pilot program will help the U.S. Food and Drug Administration (FDA) make transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments, the agency said in a June 2024 press release. The announcement comes on the heels of FDA’s final rule regarding increased oversight and enforcement of laboratory-developed tests for conditions such as cancer.
July 19, 2024