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

Tala Fakhouri blames both companies and the FDA for creating unnecessary hurdles

Tala Fakhouri, a former FDA official, is chief AI and regulatory strategy officer at Parexel.Alex Hogan/ STAT

Brittany Trang, Ph.D., covers AI in health and medicine: Does it actually work? Who benefits, or might be harmed? She writes the weekly AI Prognosis newsletter. Follow her on Threads, Mastodon, and Bluesky. You can reach Brittany on Signal at btrang.01.

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.