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Documento fuente o registro público

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

Fuente

This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices

fda.gov · Consultado el 2026-10-19

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

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Reviewer

Automated source verification

Published

2026-10-18

Updated

2026-10-20

Disclaimer

professional use

References

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