Lexology May 15, 2023
On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between FDA’s Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH), including its Digital Health Center of Excellence (DHCoE). The paper is neither FDA guidance nor policy but aims to initiate stakeholder feedback and promote subsequent discussions to help inform future regulatory activities.
The paper discusses the considerations and concerns for the use of artificial intelligence and machine learning (AI/ML) in drug development. While some existing standards and practices may be applicable...
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