Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021

Affiliations

• ¹ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ² Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ³ Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁴ Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.