The U.S. FDA announced this week that it deployed a generative AI tool called ELSA, now in use by staff across the agency, several weeks ahead of its original schedule.

FDA Commissioner Marty Makary committed to Sen. Josh Hawley that the agency will conduct a safety review of the abortion pill mifepristone.

The FDA may be facing a 4% cut to its overall budget courtesy of the Trump administration, but that hasn’t stopped the agency from unveiling a new generative AI tool a month ahead of schedule.

The FDA launched a generative artificial intelligence (AI) tool, dubbed Elsa, designed to help employees such as scientific reviewers and investigators work more efficiently, the agency announced ...

The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread ...

Following a successful pilot, the Food and Drug Administration unveiled its in-house large language model designed to help agency staff in drug clinical evaluations and reviews. FDA Artificial ...

READ: FDA promises to cut by half approval time for new products No hike for decades. The rate of fees and charges of the FDA has not been updated for more than 20 years since the implementation ...

FDA warns of severe itching risk when stopping long-term use of allergy medications cetirizine and levocetirizine, affecting quality of life for some users.

Expert advisors for the Food and Drug Administration met Thursday to discuss which virus strain this year's updated COVID-19 vaccines should target. The advisors have been meeting around this time ...

Amid concerns about FDA’s capacity to meet safety mandates following the departure of 3,500 employee since January, the agency signals a new direction for inspections and ability to do more with ...

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes.

The FDA has updated warning labels for Pfizer's Comirnaty and Moderna's Spikevax COVID-19 vaccines to note a rare risk of myocarditis and pericarditis, especially in males aged 16–25.