In Bloomberg Law, Sarah Blankstein Discusses Complexities with Incorporating AI and Real-World Data in FDA Drug Applications

The U.S. Food and Drug Administration (FDA) recently finalized guidance on using electronic health records and medical claims data in clinical studies to support drug and biologic regulatory decision making. The FDA guidance acknowledged the potential value of artificial intelligence when collecting and analyzing such data, as well as the need for caution.

In a Bloomberg Law article, life sciences regulatory & compliance counsel Sarah Blankstein discussed the complexities with using AI in real-world data analysis to support FDA drug approvals.

“The challenge is that both real world evidence and AI are things that FDA is just now having to develop policies and approaches on. The FDA understanding and approach is still evolving. So using AI tools and real-world data is going to add some additional complexity and uncertainty into an application,” said Sarah.