2023-09985: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the publication of a discussion paper entitled "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products." To fulfill its mission of protecting, promoting, and advancing public health, FDA's Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH), including the Digital Health Center of Excellence (DHCoE), is issuing this document to facilitate a discussion with stakeholders on the use of artificial intelligence (AI) and machine learning (ML) in drug development to help inform the regulatory landscape in this area.
The agency’s own summary, as published.
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