SAN DIEGO — Tala Fakhouri, chief AI and regulatory strategy officer at Parexel, stated in 2026 that industry interpretations of Food and Drug Administration (FDA) AI guidance exhibit excessive conservatism. Fakhouri is a former official at the FDA who left the agency in the summer of 2025.

Before joining Parexel, a contract research organization, Fakhouri wrote AI policy at the FDA two years prior to July 2026. She said that she observes the industry interpreting this guidance in a specific manner.

"I'm seeing the industry interpreting that guidance in the most conservative way possible in order to avoid risk," Fakhouri said. She added, "The FDA's intent to be flexible is getting lost in translation."

Why It Matters

Fakhouri's observations describe a dynamic between regulatory guidance and industry adoption concerning artificial intelligence in a regulated sector. Her insights are based on her experience both writing AI policy for the FDA and her current role at Parexel, which offers contract research services to the pharmaceutical and biotechnology industries. Fakhouri's comments suggest that the practical application of FDA AI guidance may differ from its intended flexibility.