"FDA and EMA release collaborative AI framework for drug development" was originally created and published by Pharmaceutical ...

FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...

Top of the list is that AIs must be human-centric by design and align with ethical values. They must be developed using a ...

The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and responsible ...

EMA and FDA define ten principles for AI use in medicines – in response to growing pressure from the industry.

Drug manufacturers' use of AI has recently increased significantly, according to the FDA. Here's how the agency says the ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...