Companies are being too conservative in how they interpret FDA's AI guidance, but the agency can do more to help, too, Tala Fakhouri says. research Vaccines Congress Newsletters Log In My Account Subscribe Now My Account Settings Complete your personal information for a more tailored experience Billing Log Out A decade of reporting from the frontiers of health and medicine Newsletters Log In My Account Subscribe Now Biotech Pharma Public Health Health Tech Policy Science First Opinion STAT+ STAT Events Search Log In Try STAT+ My Account Home Health tech A former AI regulator, now in industry, says biopharma is…
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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