FDA releases its latest batch of Warning Letters that include Foshan Jinxiong Technology and Sichuan Friendly Pharmaceutical Co.
Fagron Sterile Services recalls two lots of neostigmine methylsulfate 5ml syringes after a confirmed customer complaint that some syringe units are in...
The BMJ reports on a Science investigation into potential conflicts of interest with some FDA advisory committee members.
FDA warns Chinas Sichuan Friendly Pharmaceutical Co. about significant CGMP deviations in its production of active pharmaceutical ingredients.
Two attorneys say the Justice Department is quietly implementing a new policy encouraging coordination among regulators in imposing punishment on comp...
FDA clears an IsoRay 510(k) for its GammaTile brachytherapy technology that uses proprietary Cesium-131 seeds within customizable collagen-based carri...
New Jersey Democrat Frank Pallone says the House Energy and Commerce Committee should hold a hearing on drug company efforts to use the FDA REMS proce...
FDA clears an Oculocare Medical 510(k) for Alleye, a mobile medical software application indicated for detecting and monitoring age-related macular de...