Lessons Learned From the FDA’s Regulation of Emerging Technologies

Pharmaceutical Executive January 10, 2024
Andy Studna

A commentary by former FDA Commissioner Scott Gottlieb, MD, addresses uncertainty regarding how the FDA will regulate new technologies, such as artificial intelligence.

In a commentary published on the JAMA Forum, former FDA Commissioner Scott Gottlieb, MD, recalls the lessons he learned during his time overseeing the FDA’s approach to regulating medical technologies. With the recent boom in artificial intelligence (AI), and its ability to create language models on clinical datasets, there is great potential for the advancement of medicine. However, there is uncertainty regarding how the FDA will regulate these new technologies, according to Gottlieb.

“In approaching this challenge, lessons can be drawn from how the FDA has approached regulation of other new technologies,” Gottlieb wrote. “I faced some...

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