STAT+: A former AI regulator, now in industry, says biopharma is reading FDA’s guidance wrong

SAN DIEGO — Two years ago, Tala Fakhouri was writing AI policy at the Food and Drug Administration. 

Now, after leaving the FDA last summer, she’s getting a firsthand look at how the industry is implementing the policies she wrote as chief AI and regulatory strategy officer at Parexel, a contract research organization. 

What she sees distresses her. The FDA’s intent to be flexible is getting lost in translation, she said, and she’s seeing the industry interpreting that guidance in the most conservative way possible in order to avoid risk. 

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