Citing potentially lethal risk, an FDA Early Alert says Fresenius Kabi is recommending updates to some software for its Ivenix Infusion System.
An FDA alert warns healthcare professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs and Endo USA.
Federal Register notice: FDA makes available a draft guidance entitled Recommendations To Reduce the Risk of Transfusion Transmitted Malaria.
FDA sends Atara Biotherapeutics a complete response letter on its BLA for Ebvallo (tabelecleucel), a monotherapy treatment for adult and pediatric pat...
FDA publishes a draft guidance on developing drugs to prevent and treat cancer-related chemotherapy-induced peripheral neuropathy.
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.
