Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program

Docket Number:: FDA-2022-D-2275
Issued by:: Guidance Issuing Office

Oncology Center of Excellence

Center for Drug Evaluation and Research

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.

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Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program

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