Former FDA AI regulator says biopharma is misreading agency's guidance, leading to overly cautious approaches

Tala Fakhouri, who wrote AI policy at the FDA, left the agency last summer and now serves as chief AI and regulatory strategy officer at contract research organization Parexel.

She says biopharma companies are interpreting the FDA's recent AI guidance in the most conservative way possible, adding unnecessary hurdles to development.

Fakhouri also urges the FDA to provide clearer, more actionable support so firms can apply the guidance without over-cautious risk avoidance.

The comments highlight ongoing challenges as the industry seeks to integrate artificial intelligence tools into drug research and development.