Federal Register notice: FDA makes available a draft guidance for industry entitled Inspection of Injectable Products for Visible Particulates.
Federal Register notice: FDA classifies the manual percutaneous surgical set assembled in the abdomen into medical device Class 2 (special controls).
CDER Office of Compliance director Donald Ashley says the Center has ramped up its enforcement of ClinicalTrials.gov compliance, specifically registra...
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.