Federal Register notice: FDA develops a list of drug products and categories of drug products that are difficult to compound.
Federal Register notice: CDRH announces a Software Precertification Pilot Program to evaluate a new approach for software products, including a precer...
FDA announces a 9/13 public workshop on Developing a Framework for Regulatory Use of Real-World Evidence.
FDA issues a safety alert after it received recent adverse event reports about Guardian Pharmacy Services compounded triamicinolone and moxifloxacin p...
Advanced Accelerator Applications resubmits an NDA for Lutathera (lutetium Lu 177 dotatate) for treating unresectable or metastatic, progressive, well...
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...