FDA clears a Sony Electronics 510(k) for its Nucleus Operating Room Imaging Management and Collaboration Control platform.
A California federal judge says an FDA suit against two California stem cell clinics should go to trial to determine whether the agency has regulatory...
A study from Florida Atlantic Universitys Schmidt College of Medicine finds that granulocyte colony-stimulating factor or Amgens Neupogen may offer a ...
Federal Register notice: FDA seeks comments on a proposed study entitled Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion....
Federal Register notice: FDA makes available a draft guidance entitled Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use Premarket Notif...
FDA releases six final and one draft guidance to further gene therapy product development.
FDA releases the FDA-483 with four observations from an inspection at the Athenex Pharma Solutions outsourcing facility.
FDA says Medline Industries ethylene oxide medical device sterilization facility in Waukegan, IL, has been voluntarily closed since 12/13/19 to finish...