Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approval...
Bard Access Systems recalls its BD 4 Fr. Single Lumen PowerPICC Catheters due to tubing that exceeded melt flow index specifications, which could lead...
QApel Medical recalls and discontinues the marketing of its 072 Aspiration System (also known under the product name Hippo and Cheetah) based on conce...
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.