Topic
Companion Diagnostics
2 articles
Companion Diagnostics
IVDR Companion Diagnostic Consultation File: How to Prepare the NB–EMA/National Authority Interface Package
How to prepare the consultation file for IVDR companion diagnostics — notified body submission to EMA or national medicinal product authorities, package contents, analytical and clinical performance evidence, drug label alignment, timing, deficiency risks, and the Team-NB V2 decision flowchart for significant changes.
17 min read2026-05-05
›Companion Diagnostics
Companion Diagnostics (CDx): Regulatory Pathways, Development, and Market Access
Complete guide to companion diagnostic device regulation — FDA CDx approval pathways, EU IVDR requirements, co-development with therapeutics, PMA/De Novo strategies, and real-world case studies from oncology to rare diseases.
52 min read2026-03-28
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