A former AI regulator, now in industry, says biopharma is reading FDA's guidance wrong

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 in…