A new Government Accountability Office report says FDA needs to evaluate its recruitment and retention efforts to support and maintain its investigato...
Federal Register notice: FDA announces a 4/12 Oncologic Drugs Advisory Committee meeting to discuss the use of minimal residual disease as an endpoint...
CDER creates a new Center of Excellence for Quantitative Medicine to advance therapeutic medical product development and inform regulatory decision-ma...
FDA posts a notification about four information collections that have been approved by OMB.
Teleflex/Arrow International recalls the Arrow QuickFlash Radial Artery Catheterization Set (wire, guide, catheter) device due to reports about a pote...
FDA approves Italfarmacos Duvyzat (givinostat), an oral drug for treating Duchenne Muscular Dystrophy in patients six years of age and older.
Federal Register notice: FDA issues an order to permanently debar Martin Valdes from providing services in any capacity to a person that has an approv...
The Federal Trade Commission files an amicus brief calling out Teva Pharmaceuticals for improperly listed patents in FDAs Orange Book.
