AI is slowly permeating all corners of the federal government, including the Food and Drug Administration, where, according ...

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

At the CTO West Coast conference, experts discussed the future of oncology clinical trials and key themes surrounding them.

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

The new FDA commissioner and Center for Biologics Evaluation and Research (CBER) director laid out their vision for the ...

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

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

The FDA plans to “rapidly make available” rare disease drugs and make use of surrogate endpoints to get promising medicines ...

Fears about the FDA imposing steep barriers to gene therapies for rare diseases appeared moot at an agency roundtable ...

The US Food and Drug Administration says it plans to use artificial intelligence to help speed the approval of new drugs and medical devices.

The FDA has launched a pilot program using generative AI to help expedite the review of drug and device applications, part of a sweeping modernization effort by the agency. The initiative, led by FDA ...

Some experts say the move undermines science, disrupts a trusted regulatory process and could sow public distrust in ...