Trust but Verify: Lessons Learned for the Application of AI to Case-Based Clinical Decision-Making From Postmarketing Drug Safety Assessment at the US Food and Drug Administration

• Main Authors: Robert Ball (Author), Andrew H Talal (Author), Oanh Dang (Author), Monica Muñoz (Author), Marianthi Markatou (Author)
• Format: Book
• Published: JMIR Publications, 2024-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Adverse drug reactions are a common cause of morbidity in health care. The US Food and Drug Administration (FDA) evaluates individual case safety reports of adverse events (AEs) after submission to the FDA Adverse Event Reporting System as part of its surveillance activities. Over the past decade, t...