FDA researchers work with industry and clinicians to determine the best way to apply modeling information to improve pediatric dose selection for rena...
FDA alerts clinical laboratory staff and health care providers that false reactivity or a false positive test result is possible with Rapid Plasma Rea...
FDA says the Getinge/Datascope/Maquet recall of Cardiosave intra-aortic balloon pumps is Class 1.
FDA modifies a Risk Evaluation and Mitigation Strategies program for mifepristone, a drug used in early abortion and miscarriage care.
Two former FDA scientists say it is a mistake for FDA and CDC to bypass advisory committees when making Covid vaccine decisions.
Sens. Cassidy and Baldwin introduce bipartisan legislation to require medical device manufacturers to comply with FDA record requests to better prepar...
FDA updates the list of off-patent and off-exclusivity drugs without an approved generic, adding some over-the-counter products.
Federal Register notice: FDA makes available a draft guidance on Referencing the definition of device in public documents.