FDA warns Ann Arbor, MI-based Xoran Technologies about Quality System Regulation violations in its manufacturing of adulterated and misbranded compute...
FDA warns Elmwood, NJ-based Phillips Precision about eight Quality System violations in its contract manufacturing of orthopedic implants and instrume...
AdvaMed recommends ways in which FDA can improve its medical device trial participation snapshot program.
The Justice Department says a former McKinsey executive pleaded guilty to knowingly destroying information central to the governments case against the...
FDA accepts for review a Johnson & Johnson NDA for TAR-200 (gemcitabine), an intravesical drug releasing system for treating certain patients with Bac...
Getinge and its subsidiary Maquet Cardiovascular recall the VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems due to the p...
Federal Register notice: FDA withdraws approval of 23 ANDAs from multiple applicants after they told the agency that the drug products were no longer ...
FDA proposes to deny a Vanda NDA for tradipitant and offers the company an opportunity to seek a commissioners hearing on the denial.
