FDA says AuroMedics recalled two lots of ampicillin and sulbactam for injection due to complaints that it contained red particulate matter.
In her annual address to the Food and Drug Law Institute, FDA chief counsel Rebecca Wood hints that the agency is working on a guidance on manufacture...
FDA permits the de novo marketing of Wilson-Cook Medicals Hemospray, a new device used to help control certain types of bleeding in the gastrointestin...
FDA qualifies the Minnesota Living with Heart Failure Questionnaire from the University of Minnesota as part of its Medical Device Development Tools p...
Serenity Pharmaceuticals petitions FDA to deny a pending Ferring NDA for Nocdurna (desmopressin) 25 mcg and 50 mcg sublingual administration for treat...
FDA posts an Akorn Form 483 from a 2016 inspection at the firms Zurich, Switzerland sterile drug manufacturing facility.
FDA approves a CardioFocus PMA for the HeartLight Excalibur Balloon, a next-generation technology for treating paroxysmal atrial fibrillation.
Terumo recalls its Sarns TCM and TCM II Cooling and Heating Systems and HX2 Temperature Management Systems due to revised cleaning instructions.