A former FDA AI regulator turned industry executive argued that biopharma is misreading the agency’s intent on AI flexibility in medical product development. Speaking after joining Parexel, Tala Fakhouri said industry is interpreting FDA guidance conservatively to avoid risk, potentially slowing teams that could otherwise use more adaptive evidence strategies. The point drew attention to how implementation differs from regulators’ stated risk-management goals, shaping how AI-enabled trial design and submissions evolve.