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...
Public Citizen petitions HHS to use its authority under 28 USC. 1498 to permit generic competitors to manufacture Novo Nordisks semaglutide, the acti...
FDA renews the Drug Safety and Risk Management Advisory Committee for an additional two years.
FDA grants Labcorp a de novo marketing authorization for its PGDx elio plasma focus Dx kitted assay.
FDA updates an Exactech recall involving its joint replacement devices manufactured between 2004 and 2021.
