ChatGPT Poses New Regulatory Questions for FDA, Medical Industry

Large language models popularized by ChatGPT show up in nearly all of FDA Commissioner Robert Califf’s speeches lately, as he makes clear he wants to get ahead of regulating the disruptive technology.

But the “how to” part has perplexed both the US drug and device regulator as well as the companies producing the LLM artificial platform that’s known in pop culture for assisting with tasks from rewriting resumes to offering relationship advice.

Large language models are “going to be transformative and it’s got to be regulated,” Califf said recently at the Biotechnology Innovation Organization convention in Boston. “We’ve met ...