Federal Register notice: FDA is correcting a 4/9 Federal Register notice about OMB approval of several information collection activities.
Federal Register notice: FDA withdraws a 1/26/2018 direct final rule to amend its general biologics regulations relating to time of inspection require...
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 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.
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.