When two of medicine’s most outspoken reformers publish a roadmap for the FDA, you expect at least coherence. Instead, we get ...

But there are limits. Some FDA staff said Elsa often gave wrong answers and has to be double-checked. Others said the tool ...

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump ...

HHS Secretary Kennedy is taking bold steps to improve vaccine safety, including transparency and replacing a Big Pharma ...

The Food and Drug Administration has gone all in on AI since Martin Makary, M.D., took over the agency, most recently ...

FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s ...

The FDA is adopting a new regulatory framework that will change the criteria for approval of COVID-19 vaccines.

Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the ...

In 2023 Dr. Vinay Prasad said that scientists who recognized the limitations of randomized-controlled trials (RCTS) were ...

In JAMA, the FDA's Makary and Prasad said they will focus on modernizing review processes and lowering drug costs but don't outright mention precision medicine.

With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed ...

It's still unclear who will replace the current panel, but experts warn Kennedy could try to appoint members who are ...