Published on in Vol 26 (2024)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/50274, first published .
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

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

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

Robert Ball   1 , MPH, ScM, MD ;   Andrew H Talal   2 , MPH, MD ;   Oanh Dang   1 , PharmD ;   Monica Muñoz   1 , PharmD, PhD ;   Marianthi Markatou   3 , PhD

1 Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States

2 Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, United States

3 School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, United States

Corresponding Author:

  • Robert Ball, MPH, ScM, MD
  • Office of Surveillance and Epidemiology
  • Center for Drug Evaluation and Research
  • US Food and Drug Administration
  • 10903 New Hampshire Avenue
  • Silver Spring, MD, 20993
  • United States
  • Phone: 1 301 796 2380
  • Fax: 1 301 796 9832
  • Email: robert.ball@fda.hhs.gov