FDA looks outward to AI, ML developers as use becomes widespread

As the use of AI and ML in regulatory submissions becomes routine, FDA’s discussion paper is a first step to getting a handle on where regulatory clarity may be needed. In a rare move, the agency plans to take its information-finding process outside the companies it regulates.

Published on May 11, FDA’s discussion paper, Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products, lays out current and potential uses of AI/ML in drug development and considerations for those uses. ...