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GUIDANCE DOCUMENT

Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff June 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
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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All written comments should be identified with this document's docket number: FDA-2022-D-2275.

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