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BIO Notebook: US FDA User Fees For AI Regulation, Partnering Strategy Evolves, And More

 
• By Pink Sheet Team

Insights from Day Two of the BIO International Convention in San Diego include user fees potentially supporting the FDA's AI ambitions, the evolving pros and cons of partnering, and J&J's view on dealmaking in 2024.

BIO 2024 Day 2
• Source: Shutterstock

The US Food and Drug Administration likely will need a risk-based approach to reviewing the artificial intelligence aspects of drug applications as the technology becomes more pervasive in regulatory submissions, Center for Drug Evaluation and Research Director Patrizia Cavazzoni said at the BIO 2024 FDA town hall.

As the use of AI in applications increases it will become both economically unrealistic and infeasible from a time perspective to do otherwise, Cavazzoni said, highlighting the costs of the...

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