CDRH releases for comment a discussion paper on cybersecurity practices associated with medical device servicing.
Several Republican members of Congress urge FDA to prioritize tests measuring the presence of T cell-mediated immunity to Covid-19.
Public Citizen says FDA acting commissioner Janet Woodcock and two other top agency officials need to resign or be fired for their roles in the accele...
FDA classifies as Class 1 a recall of the Alaris Infusion Pump Module Model 8100 Bezel, purchased or installed by Infusion Pump Repair.
CDER director Patrizia Cavazzoni says drug companies and FDA still have progress to make in ensuring diversity and health equity in clinical trials.
Industry representatives say the Model-Informed Drug Development paired meeting program started under PDUFA 6 in 2018 should be continued and expanded...
FDA authorizes another vaccine drug substance batch (15 million doses) that was manufactured at troubled Emergent BioSolutions Baltimore facility for ...
University of California San Francisco associate professor of medicine Vinay Prasad says recent FDA actions demonstrate how broken the agency is and h...