In his report, Senator Bill Cassidy suggested a slate of changes to the FDA to support broader drug access and to reduce ...

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 ...

The U.S. FDA will offer feedback and other assistance to states that want to allow importation of prescription drugs from Canada before those states submit formal proposals. The importation of ...

The advent of AI at the US Food and Drug Administration (FDA) is changing the complexion of the regulatory approval process for medical devices. In May, FDA commissioner Dr Martin Makary announced ...

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes ...