Drugs

Workshop on AI Use in Drug/Biologic Development

FDA and the Clinical Trials Transformation Initiative are hosting an 8/6 hybrid public workshop on artificial intelligence (AI) in drug and biological product development. Meeting organizers say that “AI use in drug development creates new and unique challenges that require both careful management and a risk-based regulatory framework that is built on sound regulatory science approaches.” The workshop will discuss guiding principles that are being applied by innovators and regulators to encourage the use of AI.

Reviewing real case examples, the workshop will also discuss the rationale for particular approaches, how success was evaluated, what challenges were encountered, options for scaling and wider applicability, and considerations for moving forward.

To view registration information, click here.

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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