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Guiding Principles of Good AI Practice in Drug Development: What Every Regulatory Professional Needs to Know
In January 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly published one of the most significant regulatory science documents in recent memory: Guiding Principles of Good AI Practice in Drug Development. For the first time, the world's two most influential regulatory authorities have aligned on a shared framework governing how artificial intelligence must be developed, validated, documented, and managed across the entire pharm
3 days ago12 min read