CDRH director Jeffrey Shuren says FDA is leading a group of international medical device regulators who are developing policies to regulate software a...
The 6th Circuit Court of Appeals says a suit alleging failure to provide a medication guide is preempted by federal law.
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...