FDA's new guidance on AI in drug development centers the risk introduced by the technology

FDA issues first guidance on AI in medicine development

The FDA has placed the credibility of AI's 'context of use' in pharma development at the heart of its first guidance in this area

FDA's new guidance on AI in drug development centers the risk introduced by the technology

After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug development.

FDA issues first draft guidance on use of AI in drug, medical device development

FDA Issues Draft Guidance on AI Use in Drug and Biologic Development

The FDA’s draft guidance provides a framework for assessing the credibility of AI models used to support regulatory decisions for drug and biologic submissions. Summary: The FDA has issued draft guidance to establish a framework for evaluating the credibility of artificial intelligence (AI) models used in drug and biological product development. This guidance aims to ensure AI applications meet safety, effectiveness, and quality standards, addr…

Pharma Pulse 1/7/25: FDA Issues Draft Guidance on AI in Supporting Regulatory Decisions, Strategic AI Budgeting for Pharmacies in 2025 & more

The latest news for pharma industry insiders.

FDA Announces Guidelines for Implementing Artificial Intelligence in Drug Development

The FDA has released a new draft guidance on utilizing artificial intelligence (AI) in regulatory decision-making for drug and biological product safety, effectiveness or quality. This guidance outlines a risk-based framework for sponsors to assess AI models’ credibility, supporting innovation while ensuring regulatory standards. FDA Commissioner Robert M. Califf emphasized AI’s potential to advance clinical research and accelerate product devel…