Oncology Drug Products Used With Certain In Vitro Diagnostic Tests: Pilot Program; Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, clinical laboratories, and FDA staff entitled ``Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program.'' FDA is issuing this guidance to announce and describe FDA's voluntary pilot program for certain oncology drug products regulated by FDA's Center for Drug Evaluation and Research (CDER) used with certain in vitro diagnostic tests. FDA intends to pilot a new approach to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers should meet. Through this transparency FDA seeks to support better and more consistent performance of certain laboratory-developed tests (LDTs) used to identify patients for treatment with certain oncology drug products, resulting in better drug selection and improved care for patients with cancer. The guidance has been implemented without prior comment, but remains subject to comment in accordance with the Agency's good guidance practices.