FDA warns ICU Medical that its Minneapolis, MN-based Smiths Medical ASD unit is illegally marketing adulterated and misbranded infusion pumps.
Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second year of its voluntary Quality Management Maturity Pr...
FDA Matters founder Steven Grossman says FDA commissioner Martin Makary and the Trump administration are at a crossroads and need to decide whether th...
The International Council for Harmonization endorses and releases for comment its Q1 guidance on drug product stability testing.
FDA says it has received reports of adverse effects associated with using unapproved compounded topical finasteride products.
FDA Office of Prescription Drug Promotion director Catherine Gray and deputy director Mark Askine resign their posts in the wake of their Office havi...
FDA warns San Jose, CA-based Noah Medical about Quality System violations in its manufacturing of the Galaxy System bronchoscopes and accessories.
AstraZeneca and Daiichi Sankyo report interim data from a Phase 3 trial that showed Enhertu (trastuzumab deruxtecan), in combination with Perjeta pert...
