Document published by the source itself

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

FDA source page describing its voluntary pilot program for selected oncology drugs used with in vitro diagnostic tests; participation and current status must be checked with FDA.

Technical guidanceU.S. Food and Drug Administration

Source

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.

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

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Published

2026-10-18

Updated

2026-10-19

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