FDA Will Use AI to Approve Drugs and Devices Faster

The agency launched a large-language model, dubbed Elsa, just last week to streamline operations.

It looks like there’s no limit to the uses for AI, with the US Drug and Food Administration (FDA) announcing that it plans to use the technology to approve drug and medical devices faster in the future.

It seems like AI is being added to everything in 2025. From business software to social media apps, generative AI has found its way into every day life in more ways than we can count.

Now, the government may start using AI to speed up approval for things like vaccines and gene therapy. We just hope they’ve ironed out all the AI errors by then.

FDA Wants AI to ‘Radically Increase Efficiency’

According to an article published in JAMA, the FDA is exploring the possibility of using generative AI technology to “radically increase efficiency” when it comes to reviewing new drugs and medical devices.

“The advent of generative artificial intelligence (AI) holds several promises to modernize the FDA and radically increase efficiency in the review process.” – Dr. Marty Makary, the FDA commissioner, and Dr. Vinay Prasad,  head of the vaccine and gene therapy division, in the JAMA article

With review times often in the months to years range, the FDA could certainly use a bit of help in addressing the needs of the public.

How Will the FDA Use AI?

Everyone says they’re using AI in 2025, but how does the FDA actually plan to take advantage of the technology to improve efficiency at the agency?

Well, just last week, the FDA launched Elsa — a large-language model similar to ChatGPT — to streamline operations where possible. The AI model is used to “summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.”

 

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Given it’s only been around for a week, the agency is confident that its functionality will branch out substantially to include data processing and other generative AI operations. But for now, they have to work out the kinks before they can move forward.

Can the FDA Trust AI Will Actually Help?

There’s no denying that AI has faced a bit of a rocky start as far as efficiency is concerned. Businesses implementing the technology haven’t seen the time-saving benefits they hoped, with many reporting that AI actually adds more tasks while not actually saving any time.

Subsequently, trusting the nation’s food and drug safety to the technology is causing a bit of a backlash. After all, AI hallucinations have become far too common, and some studies found that AI gets medical diagnosis wrong about half the time.

Even worse, the FDA admits that Elsa has seen some serious problems so far. Staff members at the agency noted that the large-language model regularly provided incorrect information and that it was really only good for summarizing text.

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Written by:
Conor is the Lead Writer for Tech.co. For the last six years, he’s covered everything from tech news and product reviews to digital marketing trends and business tech innovations. He's written guest posts for the likes of Forbes, Chase, WeWork, and many others, covering tech trends, business resources, and everything in between. He's also participated in events for SXSW, Tech in Motion, and General Assembly, to name a few. He also cannot pronounce the word "colloquially" correctly. You can email Conor at conor@tech.co.
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