Pacific Research Institute senior fellow and former FDA Office of Biotechnology director Henry I. Miller says FDAs decision to recommend a pause on Jo...
Tenacore recalls Alaris Pumps it serviced because bezel repair posts may crack or separate leading to inaccurate fluid delivery.
Emergent BioSolutions, contract Covid-19 vaccine supplier to Johnson & Johnson, agrees to not manufacture bulk drug substances and to quarantine exist...
FDA sends Block Scientific a Warning Letter after reviewing its Web site and determining it is marketing Covid-19 test kits without agency approval, c...
Federal Register final rule: FDA amends certain medical device classification regulations to exclude certain software functions from the definition of...
Federal Register notice: FDA clarifies that despite enforcement discretion efforts during the Covid-19 pandemic, Class 1 surgeon and patient examinati...
FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) for combination use with chemotherapy for the initial treatment of patients with advanced or met...
Becton Dickinson recalls (Class 1) its CareFusion 303 Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry.