The DC Circuit Court of Appeals affirms a lower court decision that FDA is not afforded discretion when a combination product meets the definition of ...
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...