Drugs

CDER Publishes AI/ML Discussion Paper

CDER director Patrizia Cavazzoni says the Center has published a discussion paper, Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products, to initiate a discussion with interested parties in the medical products development community on using artificial intelligence/machine learning (AI/ML) in drug and biologic development, and the development of medical devices to use with the treatments. Writing in an FDA Voices online post (contains links to discussion papers and other resources), Cavazzoni says the paper is a collaboration between CDER, CBER, and CDRH, including the Digital Health Center of Excellence.

The paper includes an overview of the current and potential future uses for AI/ML in therapeutic development, she says. It also looks at the possible concerns and risks associated with these innovations and ways to address them. And there are questions to consider and a call for engagement and collaboration among the biomedical community.

Cavazzoni says CDER is planning a workshop to discuss how the community can work together to realize the potential of AI/ML for product development while being mindful of potential challenges.

To further address the use of AI in drug manufacturing, Cavazzoni writes, CDER also published a discussion paper, Artificial Intelligence in Drug Manufacturing, as part of the Framework for Regulatory Advanced Manufacturing Evaluation initiative. “AI technologies are important in drug manufacturing because they can enhance process controls, identify early warning signals, and prevent product losses,” she says. A second workshop is being planned to consider items from this paper.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome