Background graphic
Log InTry NAVJUN

Regulatory Intelligence Insights

Stay ahead of global compliance trends with expert analysis, regulatory updates, and product development intelligence.

No items found.

Drug Intelligence

EU AI Act: Implications for Pharma R&D Workflows

The EU's new AI regulations introduce significant compliance requirements for pharma companies using AI-driven drug discovery and clinical trial tools.

Regulatory Affairs

FDA Digital Health Center: Q1 2025 Guidance Updates

New guidance from FDA's Digital Health Center clarifies pathways for AI/ML-based software as a medical device submissions.

Market Access

HTA Methodology Overhaul: NICE 2025 Framework

NICE has published updated guidance on economic modeling for high-cost therapies, with new thresholds for gene and cell therapy submissions.