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EMA Regulatory Guidelines · EU-wide · 9 Nov 2026 · Guidance

Draft guideline on predictive biomarker assays in the context of medicinal product lifecycle

Read at EMA Regulatory Guidelines ↗
PharmaceuticalsMedical Devices & IVDClinical Trials & Research
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EMA guidance on the role and qualification of predictive biomarker assays across drug development, authorisation and post-market phases.