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EMA (EU)
GUIDANCE FINAL
Draft guideline on predictive biomarker assays in the context of medicinal product lifecycle
Published: 11/9/2026Detected: 11/9/2026

Summary preview

Clarifies how EMA expects predictive biomarker assays (including candidate companion diagnostics) to be developed, validated, and maintained across the medicinal product lifecycle.

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oncology
immunology
infectious_disease
cardiology
neurology
hematology
respiratory
gastroenterology
dermatology
psychiatry

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