FDA and CTTI To Host a Public Workshop on AI in Drug and Biological Product Development

On Tuesday, August 6, 2024 from 10 AM to 5:30 PM EDT, the FDA and the Clinical Trials Transformation Initiative (CTTI) are hosting a hybrid public workshop on artificial intelligence (AI) in drug and biological product development. The workshop is free to attend.

AI holds great potential to transform how drugs are developed, manufactured, and utilized. As with any innovation, 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.

This public workshop will explore guiding principles that are being applied by innovators and regulators to promote the responsible use of AI in the development of safe and effective drugs.

Participants have the option to attend virtually or in-person in the FDA Great Room located at 10903 New Hampshire Avenue, Silver Spring, MD 20993.

Registration information can be found here.