Researchers publish two journal articles relating to rare disease drug development.
Federal Register notice: FDA reschedules a previously planned drug safety advisory committee involving opioid overdose risk studies.
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...
A citizen petition urges FDA to amend the requirements under 21 CFR Part 211 (finished pharmaceuticals GMPs) to mandate the use of separate sampling l...