Federal Register notice: FDA classifies the assayed quality control material for clinical microbiology assays into Class II (special controls).
Federal Register notice: FDA classifies the balloon aortic valvuloplasty catheter into Class 2 (special controls).
Hi-Tech Pharmaceuticals asks the 11th Circuit Court of Appeals to rule that its synthetic DMAA, an amphetamine derivative, is a legitimate dietary sup...
FDA approves a Quantel Medical PMA for the Easyret fully integrated 577nm yellow photocoagulator, indicated for use to treat certain forms of macular ...
A Tennessee federal court enters a permanent injunction stopping Crown Laboratories from distributing unapproved and misbranded drugs.
FDA medical reviewers say that the Dynavax Heplisav-B hepatitis vaccine is effective but may have safety issues.
FDA commissioner Scott Gottlieb says the agency will postpone sending reduction-in-force notices to staff who are funded by user fees until 9/30 unles...
A Hyman, Phelps & McNamara petition asks FDA to require an explanatory footnote in the Synergy labeling for Trulance indicating that diarrhea adverse ...