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374 Therapeutic Class Labeling of EGFR Companion Diagnostics (CDxs)

OBJECTIVES/GOALS: Review all approved companion diagnostics (CDxs) labeling for therapeutic class language. Examine the regulatory pathways of CDx products whose labels contain therapeutic class labeling. Develop recommendations for pharmaceutical industry professionals on best practices in the co-d...

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Detalles Bibliográficos
Autores principales:	Chen, Joyce, Cooper, Lisa
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Cambridge University Press 2022
Materias:	Valued Approaches
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9209237/ http://dx.doi.org/10.1017/cts.2022.213

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