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...
Public Citizen petitions HHS to use its authority under 28 USC. 1498 to permit generic competitors to manufacture Novo Nordisks semaglutide, the acti...
