This draft guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

US FDA issues guidance on modernizing statistical methods for clinical trials: Maryland Wednesday, January 14, 2026, 09:00 Hrs [IST] The US Food and Drug Administration today publ ...

AI has evolved significantly, shifting from narrow, task-specific automation to advanced Cognitive Intelligence Platforms ...