FDA issues first recommendations on AI for drug development

Posted: 7 January 2025 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. The guidelines address the safety, effectiveness or […]
FDA issues first recommendations on AI for drug development