Comment from International Consortium for Innovation & Quality in Pharmaceutical Development (IQ Consortium, www.iqconsortium.org)

Summary: The International Consortium for Innovation & Quality in Pharmaceutical Development (IQ) supports the draft guidance, commending its flexible, risk-based framework for using AI in drug and biologic development. They provide numerous specific recommendations to improve the guidance's clarity on software requirements, reproducibility, data management, model evaluation metrics, and regulatory engagement.