As the FDA Goes AI-First, Biopharma Must Rethink Regulatory Operations

An Expert View from Lindsay Mateo, chief commercial officer at Weave Bio.

The US Food and Drug Administration (FDA) is moving rapidly to modernize its regulatory review processes, with artificial intelligence (AI) set to play a central role. By June 30, the agency aimed to fully integrate AI tools into core operations, fundamentally changing how it manages the review and approval of drugs, biologics, and medical products.

While much of the recent media attention has focused on the FDA’s decision to reduce its workforce by 20%, this move is only one element of a broader operational overhaul. The real story is the agency’s accelerated push to automate labor-intensive review tasks, extracting key decision points from vast, complex data submissions and flagging inconsistencies or outliers with major improvements in speed and precision.