FDA clears a Vapotherm 510(k) for its latest version of its Precision Flow Hi-VNI system, which includes a new product category and product code QAV.
Federal Register notice: FDA requests comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling cha...
A federal government brief tells the Supreme Court that the 3rd Circuit Court of Appeals erred in reversing a lower court decision supporting preempti...
FDA releases its latest batch of Warning Letters that includes one medical product company Becton Dickinson.
FDA warns Becton Dickinson about Quality System issues at one of its manufacturing facilities.
FDA issues guidances to promote development of generic transdermal and topical delivery systems.
Qualigen has submitted a 510(k) for its FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay, indicated for the quantitative determination of S...
FDA medical reviewers tell members of the Anesthetic and Analgesic Drug Products Advisory Committee that they believe Trevenas oliceridine has a poten...