FDA says its work implementing the Drug Quality and Security Act has included stepped up inspections at drug compounders that led to corrective action...
FDA clears a SonaCare Medical 510(k) for its latest version of Sonablate, a high-intensity focused ultrasound device intended for focused ablation of ...
A QuintilesIMS Institute report reviewing 20 years of biopharmaceutical innovation says that the industry is robust and has launched 667 biopharmaceut...
CDER says it will publish 101 new and revised draft guidances in this fiscal year.
FDA makes recommendations to reduce the risk of adverse events in patients with implantable infusion pumps undergoing MRI exams.
FDA accepts a Mylan BLA for a biosimilar version of Genentechs Herceptin.
A Tufts Center for the Study of Drug Development survey shows that lack of healthcare provider engagement in the process is hurting clinical trial rec...
Bayer begins a Class 1 recall of its Medrad Intego PET Infusion System Source Administration Sets due to particulates generated in vials.