Federal Register notice: FDA makes available a publication entitled Modifications to the List of Recognized Standards, Recognition List Number: 058....
FDA says it will temporarily allow distribution of some sitagliptin products with the nitrosamine impurity NTTP above acceptable intake levels to avoi...
Five stakeholders comment on an FDA draft guidance on radiolabeled mass balance studies.
FDA clears ReShape Lifesciences Gastro Intestinal Balloon Indicator calibration tube in three sizes.
FDA and commissioner Robert Califf launch a new 'Rumor Control' Web page as part of the agency's first effort to address misinformation.
FDA warns Natick, MA-based Zyno Medical about Quality System and other violations in its production of infusion pumps and administration sets.
FDA clears a Bodyport 510(k) for its biomarker platform Bodyport Cardiac Scale that is intended to assess measures of heart function and fluid status ...
FDA sends CorMedix a second complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure p...