A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligence to meet new demand...
Three FDA staffers discuss the agencys efforts to advance the use of digital health technologies in clinical trials.
Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approval...
FDA appoints Capitol Hill staffer Grace Graham as deputy commissioner for policy, legislation, and international affairs.
FDA is recruiting contractors to do the travel logistics work for inspections and investigations that was done by staff who have been fired, according...
FDA issues two documents answering frequently asked questions about reporting medical device recalls, corrections, and adverse events.
FDA grants interchangeable biosimilar status to Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.
A presidential executive order tells FDA to suggest administrative and legislative ways to improve the availability of generic and OTC drugs and to ma...