Zdrowie i gospodarka · 14/04/2020

FDA Releases Guidance for Companion Diagnostic Devices for Oncology Therapeutic Products

The US Food and Drug Administration (FDA) has released a final guidance for industry on developing and labeling in vitro companion diagnostic devices for specific oncology therapeutic products, particularly those targeting nonsmall cell lung cancer patients with EGFR mutations. The guidance encourages the submission of premarket approval application supplements to modify companion diagnostic use.