Fresenius Kabi recalls its Ivenix Infusion System due to a leak in the device that allows fluid to enter the administration set loading area.
Federal Register notice: FDA seeks comments on an information collection extension entitled Rapid Response Surveys.
Federal Register notice: FDA revokes the emergency use authorizations issued to BioFire Defense for the FilmArray NGDS BT‐E Assay, and Biocartis...
FDA warns Holly Hill, FL-based North American Diagnostics it is illegally manufacturing and distributing adulterated and misbranded Covid-19 test kits...
FDA publishes a draft guidance with information and recommendations to assist in developing drugs to prevent or treat acute radiation syndrome.
The National Cancer Institute says Syndax Pharmaceuticals revumenib shows promise in treating some acute myeloid leukemias.
FDA says drug compounders should be sure the active pharmaceutical ingredients and excipients they use have been evaluated by their suppliers for puri...
ProPublica says FDA foreign drug manufacturer inspections remain well below pre-pandemic inspection levels.
