Today, the U.S. Food and Drug Administration issued a discussion paper, "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products." The discussion paper is intended to initiate communication surrounding artificial intelligence and machine learning (AI/ML) with stakeholders, including industry and academia, to promote mutual learning and discussion.
FDA is soliciting feedback on the opportunities and challenges with utilizing AI/ML in drug development and medical device development for drugs. This discussion paper will complement and inform future guidance on AI/ML in drug development. Specifically, the questions in Section B aim to initiate a discussion with stakeholders and solicit feedback on three key areas in the context of AI/ML in drug development.
------------------------------
Kelly H. Zou, PhD, PStat, ASA Fellow
Vice Chair, Methods and Data Council
AcademyHealth (with ASA as an Organizational Affiliate)
------------------------------