The Government Accountability Office says Medicare spends almost 60% of its drug budget on products that are advertised to consumers.
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.
FDA accepts for priority review a United Therapeutics NDA for Tyvaso DPI (inhaled treprostinil) for treating pulmonary arterial hypertension.
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...