Experts Urge FDA To Define Key Terms In Upcoming Guidance On AI Use

As FDA’s drug center gears up to issue guidance on use of artificial intelligence to enhance its regulatory decision-making, industry experts are urging the agency to provide explicit definitions for the terms "safe," "responsible," and "ethical" use of AI rather than leaving the terms open for interpretation. Wendy Cheng, managing director in Berkeley Research Group (BRG), tells Inside Health Policy that FDA needs to clearly state in its forthcoming guidance what exactly it means for AI to be used...