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...
King & Spalding hires former FDA associate commissioner for policy Lauren Roth as a partner on the FDA and Life Sciences team.
FDA approves Eli Lillys Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohns disease in adults.
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 ...