Day: January 15, 2026

What if your clinical trial could formally learn from the past, without sacrificing regulatory rigor? What if probability itself became part of the evidence FDA evaluates? With its new draft guidance, FDA explains how Bayesian methods, that were previous described for medical devices, can be used for drugs and biologics as well, but with guardrails. … Read more

Artificial intelligence is increasingly embedded within FDA-regulated drug development activities, from nonclinical modeling to clinical trial execution and post-market surveillance.As AI systems begin to influence regulatory decision-making, FDA expectations for validation, control, and documentation are converging with established GxP software requirements.This week the FDA and EMA jointly released the Guiding Principles of Good AI Practice … Read more