FDA, EMA Drug Development AI Principles
Following several months of collaboration, FDA and the European Medicines Agency have published a document outlining 10 guiding principles for good artificial intelligence (AI) practice in drug development. An FDA statement says the “integration of AI in drug development has the potential to transform the way drugs are developed and evaluated, ultimately improving healthcare…. These 10 guiding principles lay the foundation for developing good practice that addresses the unique nature of these technologies and identifies areas for potential collaboration by international regulators, international standards organizations, and other collaborative bodies.”
The 10 principles are:
- human-centric by design;
- risk-based approach;
- adherence to standards;
- clear context of use;
- multidisciplinary expertise;
- data governance and documentation;
- model design and development practices;
- risk-based performance assessment;
- life-cycle management; and
- clear, essential information.