Top of the list is that AIs must be human-centric by design and align with ethical values. They must be developed using a ...
FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...
The joint guidance was created to ensure drug developers employ best practices when using AI.
The European regulator’s anniversary year featured first-in-class therapies, rare-disease advances, safety warnings, and new rules reshaping how medicines reach patients.
EMA and FDA define ten principles for AI use in medicines – in response to growing pressure from the industry.