Document published by the source itself
Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
FDA guidance on development and labeling considerations for companion diagnostics intended to support a group of oncology therapeutic products.
Technical guidanceU.S. Food and Drug Administration
Source
This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices
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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2026-10-18
2026-10-19
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