Zdrowie i gospodarka · 21/06/2023

FDA Releases Guidance on Oncology Drug Products Used with In Vitro Diagnostic Tests

The Food and Drug Administration (FDA) has released a final guidance document outlining its voluntary pilot program for certain oncology drug products used with in vitro diagnostic tests. The program aims to provide greater transparency regarding performance characteristics of these tests to support better and more consistent laboratory-developed tests, ultimately leading to improved care for cancer patients.