USA – AI in drug development: FDA draft guidance addresses product lifecycle, risk

The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or information that supports regulatory decision-making in submissions for drugs and biological products. In the draft guidance, FDA proposes using a risk-based credibility assessment framework for AI use in product submissions based on context of use (COU). The framework would apply when AI produces information or data that would lead to a regulatory deci...