Medtronic recalls (Class 1) its NIM Vital Nerve Monitoring System to conduct a product correction due to reports of false negative responses.
FDA warns Chinas Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. about CGMP violations in its production of finished drugs.
Federal Register notice: FDA announces a 9/6 public workshop entitled Enhancing Diversity in Therapeutics Development for Pediatric Patients to discus...
The Justice Department says a Virginia man who pleaded guilty to distributing misbranded drugs via the Internet has been sentenced to two years in fed...
Foundation Medicine petitions FDA to reclassify all next-generation sequencing oncology panel devices used for somatic or germline variant detection t...
FDA warns Melville, NY-based Velocity Pharma that it has received and distributed adulterated eye drop products produced for it by a contract manufact...
FDA clears a Pentax Medical 510(k) to acknowledge its DEC (Disposable Elevator Cap) Duodenoscopes compatibility with Advanced Sterilization Products S...
Federal Register notice: FDA announces the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two.
