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

Issue Date: June 20, 2023
Issued by: Oncology Center of Excellence
Topic(s):
Status: Final

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

Center for Devices and Radiological Health FDA is issuing this guidance to announce and describe FDA’s voluntary pilot program for certain Center for Drug Evaluation and Research (CDER)-regulated oncology drug products used with certain in vitro diagnostic tests.

Download the Guidance Document