FDA warns two companies selling dietary supplements containing tianeptine.
FDA classifies as Class 1 a Beckman Coulter recall of two models of flow cytometers due to an electrical circuit error.
FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren discuss steps being taken to ensure that FDA is consistently the first regulatory age...
FDA clears a SIG Medical 510(k) for its AdvantageRib Anterior System, intended for the fixation, stabilization, and fusion of rib fractures and osteot...
Federal Register notice: FDA determines that 47 drug products it is listing were not withdrawn from sale for reasons of safety or effectiveness.
FDA and Duke-Margolis Health Policy Center plan an 11/27 public meeting to seek stakeholder input on long-term solutions to address the drug shortage ...
FDA approves an expanded label for Novartis Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and old...
FDA alerts health care professionals and patients not to use drug products produced and distributed by Pharm D Solutions (Houston, TX) due to lack of ...